chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient originally seen in ER for "nail gun injury L Thumb. Given dTap on 5/5/06 Returned 5/6/06 with fever 102.3; generalized body aches; no rash
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, several hours after receiving SHINGRIX, the patient experienced general body pain and shivering. On 1st August 2018, the patient experienced weakness. On an unknown date, the outcome of the general body pain, weakness and shivering were recovered/resolved. It was unknown if the reporter considered the general body pain, weakness and shivering to be related to SHINGRIX. Additional information was received as follows: At 14:00, the patient received SHINGRIX on the right arm. The patient stated that the night of vaccination she experienced body ache, and shivering. Next day, the patient experienced weakness. The patient had denied permission to contact their physician. No further details were provided.
Diarrhea; Hair loss; Appetite change; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Breast cancer.    Concurrent medical conditions included Breast cancer (Breast cancer / malign neoplm of upper-outer quadrant of right female breast /  2+ breast cancer.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) 150 mg. On an unknown date, TUCATINIB (TUKYSA) (unknown route) dosage was changed to 150 mg and TUCATINIB (TUKYSA) (unknown route) dosage was changed to 150 mg. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change). At the time of the report, DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Patient reported date of birth as 1948 (Adult)
SHINGLES VACCINATION IN LEFT ARM.  HIVES ALL AROUND TORSO ON LEFT SIDE.  TWO OR THREE ON RIGHT ARM, THEN MY LEFT EYE BEGAN WEEPING CONSTANTLY. I'M USING ARTIFICIAL TEARS IN MY EYE AND I'M USING CALAMINE LOTION ON THE HIVES, i HAVE TAKEN 500MG OF TYLENOL TWICE AND DIDN'T NOTICE AND DIFFERENCE. THE HIVES ARE STILL OCCURING BUT DO SEEM TO BE SLOWING DOWN.
12:15 - Pt in today for yellow fever and Hep A vaccine for travel to Peru. Vaccine was given (yellow fever) SQ in left arm and Hep A IM in R deltoid at 11:45 am. Pt started c/o feeling tired, then mild SOB, just not being able to take a deep breath. Hives appeared on neck, bright red splotchie but non-puritic. B/P 163/96 P- 110, O2 SAT 99%, lips pink. Doctor notified immediately. 12:20 Epi .3 cc SQ given in L arm, pt. began feeling light headed and dizzy. Transport from immunization room to u/s room via WC. Assisted from chair to wheel chair and then from wheel chair to exam table. Upon transfer from wheel chair to exam table pt reported that her legs were weak feeling and very heavy. Doctor aware of legs feeling weak and very heavy. B/P 168/100 P- 98; O2 Sat 99% lying on exam table with head down and feet elevated. 12:25 Pt remains stable, no change in condition except lips starting to tingle slightly. SOB has subsided some. Spoke with Doctor about pt starting to have some tingling sensations in her lips. Orders received at this time 1 SOLUMEDROL 125 mg IM and 2 BENADRYL 50 mg po (stat). 12:30 BENADRYL 50mg po given and SOLUMEDROL 125 mg IM given in R hip. B/P 155/98 P- 96; O2 Sat 99%. Significant other notified of his need to come to health dept that his wife was having an allergic reaction to the Yellow Fever vaccine. 12:35 Significant other present. Pt reports that she is feeling "some"better. Pt was assisted to semi-fowlers position and was given some coca-cola to sip on. Pt awake, alert, orientated, talking coherently. Color is returning to lips. Hives are faded tremendously and hardly viable. Talking with significant other. 12:50 Pt was noted to take a very deep breath with a sigh and when asked she reported that the SOB, tiredness, and heaviness of her legs were returning. Pt asked to be laid back down in supine position. B/P 152/99 HR - 98. Doctor notified. 12:53 EMS called for a 1018 transport to medical center secondary to an allergic reaction to yellow fever vaccine. 12:55 Pt cont. to be the same, mild SOB, lips tingling, able to talk and communicate. 12:57 B/P 164/103 P - 101 O2 Sat 98%. Pt encouraged to take slow deep breaths. Significant other at bedside. 12:59 Pt c/o being unable to swallow and her tongue was numb. Dr. notified orders recovered 1 Epi .3 SQ (STAT) 13:00 Epi .3 cc SQ given in R arm. Talked with pt and encouraged to calm down and take slow deep breaths. 13:02Pt reports that she is starting to get some feeling back in her tongue. 13:04 Pt remains stable, she reports that the SOB is easing some, the tingling is gone in her tongue. 13:05 EMS arrived. Report given and meds and dosages given.
I did not feel right and then I had a headache; chills; I did not feel right and then I had a headache; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left (reported as "Left shoulder") on 29Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported couple hours like 3-4 hours afterwards she had chills, did not feel right and then had a headache. Patient started experiencing problem at night. Events outcome were unknown.  No follow-up attempts are needed. No further information is expected.
ONSET OF FEVERS, SWEATING, CHILLS, MYALGIAS, CORYZA, SINUS CONGESTION, CHEST CONGESTION WITHIN 24 HRS OF RECEIVING VACCINE
14 hours after shot, mild headache began. Headache lasted for 12 hours. Also at 16 hours post shot, I had severe chills that lasted for approx 30 min.
breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (breast cancer) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient states she has two friends with breast cancer after shots 5 and 6. No treatment medication reported.  This case was for the first of two patients reported. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant ) unexpected, event of breast cancer, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The outcome of the event was reported as not recovered. The event was considered unrelated to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748863, US-MODERNATX, INC.-MOD-2023-750551 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live follow-up received with no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748863:Different patient US-MODERNATX, INC.-MOD-2023-750551:Different patient
Patient got the Pfizer vaccine after receiving the Moderna vaccine on 2/25/21 for her first injection.
Adverse Reaction Notes 59 y/o Haitian female with no past medical HX c/o "head heaviness" and dull neck pain 10/10 after receiving the 2nd dose of the vaccine. She reported that she had neck pain with the first dose but this time the pain is worse. She was assessed and monitored by NP, EMT, and paramedic. Initial BP - 204/110, 190/100, HR - 88, resp- 14, O2 sat 96% on RA. BP remained at 190/100 and she reported that she felt weak and dizzy. EMS called to take her to ED for eval and TX. Husband with pt and agreed with TX. She is awake, alert, oriented to person, place, time and situation, MAE. Pupils size 3mm, PERRL. Transported from site via stretcher by EMS personnel to go to ED.
Inappropriate route of vaccination; cellulitis/ cellulitis from the injection site down to the antecubital fossa; swelling; rash look like cellulitis-red; minimal itch; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of cellulitis of arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in March 2019).   On 1st October 2019, the patient received the 2nd dose of Shingrix. On 1st October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th October 2019, the patient experienced cellulitis of arm (serious criteria GSK medically significant), swelling, red rash and pruritus. On an unknown date, the patient experienced intramuscular formulation administered by other route. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the cellulitis of arm, swelling, red rash and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cellulitis of arm and swelling to be related to Shingrix. The reporter considered the red rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The rash started day 3 after shot and it was extended to shot site to elbow. The patient had no pain but had minimal itch. The patient received 2nd injection with similar reaction but less intense. The reporter stated that vaccine was not administered by them either time.
headache; Myalgia; This is a spontaneous report from a Non-contactable consumer. An unspecified age of male patient 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 unknown date Feb2021 as a single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Myalgia, headache.The outcome of the events was unknown.  Information on the lot/batch number has been requested
The patient has a large knot in the left thigh. Apply cool compresses and give Tylenol for pain and fever.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-AUG-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PPV23 0.5 ml IM given in deltoid - 11/3/12 pt called to report redness & swelling & stiffness in the arm shoulder to wrist - instructed to use cold compresses and Ibuprofen - resolved 2-3 days
I had covid. I pretty much had every symptom. headache, fever highest 102, chills, really bad sore throat, sinus congestion, diarrhea, fatigue. I was prescribed paxolvid on day 2. symptoms lasted about 4 days total.
Information has been received from a health professional concerning a 17 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil. Thirty days post vaccination the patient had an abnormal Pap test and was positive for high risk HPV with a DNA HPV test. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
First day felt off.  Second day had a really sore arm. Third day little sore arm. Fourth day only felt bruised where injection was.  Not red.  Day 12 rash and ring around injection site.  Day 13 gone. Day 14 warm to touch itchy rash with ring.
17DEC91 onset of fever 104, anorexia, insomnia, green nasal drainage; seen by MD; was put on Amoxicillin; 26DEC91 onset of lt parotid swelling, fever 100.6, pulling @ ear, pain w/eating; Seen by MD in ER dx mumps;
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
itchiness and mild swelling in my throat; itchiness and mild swelling in my throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Aug2021 11:45 (Lot number: FC3181) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex. There were no concomitant medications. The following information was reported: THROAT IRRITATION (non-serious), PHARYNGEAL SWELLING (non-serious) all with onset Aug2021, outcome "recovered" (2021) and all described as "itchiness and mild swelling in my throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of throat irritation, pharyngeal swelling.  Additional information-Patient had COVID-19 vaccine at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient was advised to take Benadryl for the AE. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Received HPV#3 in August 29, 2012 and on Sept 1, 2012 developed progressive bilateral leg and then back pain without clear etiology for ~6 weeks and then developed progressive leg weakness and then some upper extremity weakness over subsequent ~6 weeks. Her weakness was such that she was unable to walk. Hospitalized on 12/4 with trace reflexes by neurologist and significant leg>arm weakness. Clinical history, exam, EMG and LP all consistent with atyical Guillain-Barre of axonal variation. She received 5 days of IVIG and improved and was able to ambulate though not completely back to normal prior to discharge. Also, at admission she had fever and URI symptoms without meningismus for 1-2 days, was PCR positive for influenza B and improved within 2 days on tamiflu. No history of symptoms suggestive of lyme. Other vaccines received in 2012--HPV#1 Feb 9, 2012, HPV#2 Apr 27, 2012, Tdap 6/21/2012. Family reports no problems after any of these vaccines.
nausea, dry heaves, diaphoresis Narrative:  78 yo with PMH of CKD stage 2, hx of DVT, HTN, GERD, hx of cerebral infarction, RA, angioedema, postherpetic neuralgia, T2DM and hypothyroidism.reported feeling nauseous and dizzy after the first dose of COVID19 Pfizer vaccine on 2/4/2021. Vital signs taken: BP 122/72 HR 66, O2 99%. Pt was diaphoretic with dry heaves. Rapid response team was called, blood glucose was 116. Pt was then taken to the ED where they suspected patient had a vasovagal response. Patient was monitored for at least 45 minutes in the emergency room before discharge. Prior to vaccination, patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy.
Patient received second dose of Pfizer (tozinameran-tris-sucrose) vaccine on May 10, 2022. On May 17, 2022 patient started experiencing severe lower abdominal pain and decreased bowel movements. Patient started having nausea and vomiting the morning of May 21, 2022. Patient saw his PCP and received a sample of Trulance 3mg to take for the constipation. Patient took the first and only dose the morning of May 21, 2022 and had a bowel movement that was green/black in color. Patient came to the ER May 21, 2022 at 1656 due to this. Scans were done and it was found patient had acute appendicitis with severe surrounding inflammation as well as large fecalith with possible perforation. Patient taken emergently to OR for laparoscopic appendectomy.
Information has been received from a health professional concerning a 5 year old female who on 6/1/99 was vaccinated IM with a dose of varicella virus vaccine live. On 2/6/04 the patient developed a rash all over her body and a low grade fever. On 2/9/04, the patient was seen by the physician who diagnosed the patient with varicella. It was reported that the physician did not consider the breakthrough as serious. There were no lab tests performed. As of 2/9/04, no treatment was necessary and the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old patient, gender unspecifed. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 26-MAY-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacist. On an unspecified date, the patient experienced injury to themselves (Ill-defined disorder). On an unspecified date, the patient was treated by a health care provider. The outcome of the event injury to themselves (Ill-defined disorder) was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
I had been scheduled to have a Flu shot at clinic. I have received FLUARIX - Flu shot at clinic, and few days later I have a lot of very painful and red furuncles (like swallowing lymph node) all over my body including on my neck, head, right chest and etc. I have never experience this problem before during my entire life, and I have regularly received Flu shots every year. I am suspect something is wrong with that Flu shot from clinic. Please advise.
The night of vaccination began headache, red left arm, heavy sweating. In the days following soreness in hands, paresthesia, heart palpations and adrenaline surges. About a week out tinnitus and ear pressure began in both ears, developed cold sore and sorenss under left chin, head pressure, lightheadedness, dizziness/nausea. PCP recommended to see ENT. 1st ENT checked hearing had high end hearing loss in left ear no treament. PCP prescribed round of low dose steroid. 2nd ENT prescribed another steroid round. Neurology and Immunology apts TBD. To this day I have non-stop tinnitus and lightheadedness, faintness/fainting, dizziness/nausea, head pressure, heart palpatiations, paresthesia all severely impacting my life.
Information has been received from a registered nurse concerning his 12 month old son who on approximately 15-FEB-2006 was vaccinated with a first dose of MMR II.  The patient received the second dose of MMR II, however the vaccine components were split out and separated them by 1 month intervals.  On approximately 08-MAR-2006, three weeks after receiving the dose of MMR II the patient was diagnosed with apraxia.  This resolved within a few months with therapy. So far he had been fine.  It was also reported that one of the patient's brothers received the components of the vaccine separate by a month, and he was fine.  This is one of two reports from the same source.  Additional information has been requested.
Fever of 100F, chills, headache, nausea, fatigue --  day after  Mental foginess, low energy, swelling around injection site -- two days after Lingering pins and needles / tingling around face, dizziness standing up, general feeling of shortness of breath or pounding heart -- starting two days after and lingering thereafter.
SORE SWOLLEN LUMP AT INJECTION SITE, RED RASH ALONG ARM DOWN TO ELBOW
It started with a few itchy bumps on my upper cheek 8-9 days after the vaccine and then the small, itchy, red bumps spread all over my cheeks. Then continued spreading to my forehead and under my chin. The itchiness subsided in two days but the bumps still remain.
taste buds change; bone hurts; headache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced taste buds change, bone hurts, headache on an unspecified date. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Became sweaty and pale after injection.  Stated felt like he couldn't hear correctly.  BP 84/58, HR 61-70, PulseOX 98%.  Given 2 bottles of water, feet propped up,  and he pinked up and able to converse appropriately with staff.  Advised to stay for 30 minutes to monitor.