chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itch at injection site; Pain at injection site; scabbing at injection site, 10 areas; breast tenderness; Post menopause period; Swelling at injection site; nodule at injection site; This case was reported by a dentist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site scab and breast tenderness. On 19th November 2021, the patient experienced injection site pain. On 3rd December 2021, the patient experienced postmenopausal syndrome. On an unknown date, the patient experienced injection site nodule and injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab and postmenopausal syndrome were recovered/resolved and the outcome of the breast tenderness was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab, postmenopausal syndrome and breast tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by dentist herself.  The patient, immediately experiencing pain at the injection site, that subsided after a couple of days and experienced swelling at the injection site a couple of days after receiving first dose of Shingrix and swelling gradually got bigger and lasted approximately two weeks.  She had nodule at injection site and nodule persists for approximately two weeks and had a consistent itch for the duration of that time.  The patient reported the nodule was painful if slept on.  She experienced scabbing at the injection site approximately 12-14 days after receiving first dose of Shingrix.  The patient informed that there were approximately 10 scabbed areas around the injection site and scabbing persisted for 4-5 days, possibly longer.  She got a period on 3rd December 2021 , despite being post menopausal before receiving first dose of Shingrix.  The patient's period lasted 5 days and experienced breast tenderness a week prior to onset of period, reported having not had another period, since this occurrence. The reporter consented to follow up.
Pt. was noted to be holding breath during vaccination, and within 15-30 seconds after administration of vaccine, pt fell backwards from sitting postion. She was not verbally responsive, and was pale. Pt was laid in a supine postion and then had stiffening of the upper body with a few jerking movements of the upper extremities. Briefly her eyes rolled backwards. This lasted for approximately 5 sec, upon witch the patient came to, was alert, responsive, sat up briefly and stated she felt dizzy, sweaty, and tired. There was no loss of bowel/bladder control. Her exam and vital signs were normal. She was observed for approximately 20 min. without further problem and discharged form the office. It was noted by her mother afterwards that she had nothing to eat or drink today, and has had past pre-syncopal episode, as have multiple siblings associated with blood/blood draw, prolonged standing, and stress.
administered a Booster Dose to a patient who last received their Second; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second). On 30-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient complained of no additional events  No treatment information was provided.
J96.00 ACUTE RESPIRATORY FAILURE 2/21/2023 ALZHEIMERS DISEASE
symptoms started 11/23/21: congestion, sneezing, loss of taste/smell.
Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died; This is a spontaneous report from a contactable consumer (reporter's cousin). A 37-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, Pfizer gave the COVID vaccine to the reporter's 37 year old cousin who died The patient died on an unspecified date. It was not reported if an autopsy was performed.  Description of Product Complaint: The caller knows a nurse and said the only people in her 3 different shifts who have not been sick are all unvaxxed, all of the people who have been vaccinated are the ones with the virus. 11 percent of people in withheld are vaccinated and no one has COVID. 96 percent of people in withheld are vaccinated and 98 percent of them have COVID.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died
Pt. reported acute onset nausea with dry heaves, chills and body aches.  Treated originally treated with Zofran ODT, then IV fluids ( 1 L Normal Saline), IV meds: Benedryl, Pepcid and Solumedrol. 2 hrs after onset of symptoms, pt reports she is feeling better, nausea, chills and body aches resolved.
Tested positive for COVID after receiving series and booster; Tested positive for COVID after receiving series and booster; Feeling lethargic; low energy; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID after receiving series and booster"; LETHARGY (non-serious), outcome "unknown", described as "Feeling lethargic"; ASTHENIA (non-serious), outcome "unknown", described as "low energy"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Clinical course included that "Patient tested positive for COVID after receiving series and booster. Feeling lethargic, low energy, headache".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shortness of breath, urticaria-generalized, diffuse red rash on back, chest. tachycardia,
she did a pregnancy test and found out she was pregnant a day after receiving GARDASIL 9; This spontaneous prospective pregnancy report was received from a 27-year-old female patient referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in arm (exact dose, route of administration, lot # and expiry date were not reported) for prophylaxis to lessen risk of abnormal cells growing on cervix. On 17-SEP-2019, she did a pregnancy test and found out she was 4 weeks pregnant. The patient's last menstrual period was on 19-AUG-2019 and estimated delivery date on 25-MAY-2020. The pregnancy outcome was pending.
Per Dr. : Asked to see patient in medic treatment room 5 minutes after he received Jand J vaccine at  vaccine center. Pt. Was in observation, and began to feel lightheaded and dizzy. Pt. Felt like he would pass out. Pt. Notified observer, that got nurse. Pt. Taken by wheelchair back to Medic treatment room. Pt. VSS initially at ^30 Pm, BP 94/70, P 60, R12, O2 sat 100% on RA. No airway swelling, no rash, no wheezing. Lungs CTA B. Pt monitored. Given Sprite, crackers. Felt much better. BP at 6:37 PM was 188/82, HR 66 P Ox 100 % on RA, R12. Lungs remained clear. Pt. Back to baseline. Warning signs and symptoms discussed prior to pt leaving clinic, and pt. Verbalized understanding andd need to call 9111 if these occurred. Pt. Likely had vagal reaction, that full resolved.
Severe Tinnitus started 24 to 48 hours after 2nd Moderna shot on 4/15/21 to covid-19 vaccine. Testing & Treatment scheduled.  It continues/is unresolved, i.e., it appears to be permanent.
Minutes after both shots, my 11 year old daughter fainted and fell on the floor and was having seizure like movements with eyes rolled back in her head. She lay unconscious for a minute and then doctors put her back on exam table and she was pale. They gave her water and an ice pop.
Within minutes of receiving a flu shot, the pt developed tingling, flushedhands, palpitations, dyspnea and chest and arm pressure. He had been fasting the entire day before and moring of the shot. Brought to the observation room and given oxygen. EKG showed tall pisked p-wave. Pt also had a murmur he denied having in the past or abd EKG-referred to ER. Seen in local ER and referred to cardiologist. EKG at our facility was with tall pisked p-wave-pt had a murmur.
on 8/13/21 patient reported on the phone that there is redness at the site and seems to be warm and redness spreading . She received vaccination on 8/4/21.
Parent reported to physician's office shortness of breath, chest pain, elevated temperature, and reddish-colored rash on abdomen, back and armpits accompanied by itching. Per parent, shortness of breath and chest pain lasted 5-6 minutes and patient was given ibuprofen for the elevated temperature and cyproheptadeine tablet and Benadryl gel applied to rash. Per parent, all symptoms were resolved by the time the incident was reported to the physician's office on 7/17/2019 approximately 4:00 pm. Parent reported today that patient continues to do well and no symptoms at this time.
I had a flu shot Oct. 2, after that for the next couple of weeks, I experienced numbing and tingling in my left arms from my fingertips to my shoulderblade, I dismissed it as an 'aftereffect' of the shot. Week three went by, I went to the PCP, described the problems, She put me on Naprosyn and Neurontin, which only masked the problems, as the numbing and tingling were still there. Week four, I started having motor problems, dropping cups and plates, etc. I went to an orthopedic, everything was normal, including xray of my neck. So, onto neurologist who did a nerve conductivity test that turned out normal. . Week 5 included PAIN, and increasing into the shoulder blade. I had a full exam with the neurologist (week 6) . He has ordered Brain MRA's and C-Spine MRI tests, which are scheduled for this wed (nov.  22ndth) I have a physical therapy evaluation Tomorrow (Monday , Nov. 20th..   The neurologist seems to think the symptoms are MS- like and conclude it was probably from the flu shot.   I took blood tests today, Including SED Rate, ANA, C React Protein, and an RA test.
Broke out in rash this AM. Generalized scattered blanching M-P rash most prominent on abdomen.
Rt thigh with signs of infection 2-3 days s/p IM vaccination admin.  Pt with VIS  (Influenza, Polio, DTaP, MMRV) forms only and it is not clear which vaccines were given in the right thigh.  Pt to be treated with cephalexin antibiotics, follow up with PCP on Monday for recheck and advised to have them report the exact vaccines given with name, lot #, etc.
Sore arm 5pm day of until Monday  Fatigue  Headache Saturday night Diarrhea on Monday
2 days after 4 month shots, developed raised rash all over body. Change in personality -> lethargic, decrease in babbling and cooing, screaming, decreased eye contact - not happy. 5/1 - seizures started.
The day after the vaccination I had redness around my whole shoulder and arm. On the third day I developed swelling of my shoulder and neck with horrible pain when I breathe.   I went to urgent care and had an x-ray which was clear and they were treating me for myalgia with Motrin. I refused any narcotic pain medication or a Toradol shot.  The pain never stopped on the 19th I went to Work Force Safety and reported it and I was examined by the nurse practitioner who saw all the swelling and the pain that I was in. That nurse practitioner told me if it wasn?t better in a few days to go to the emergency room to be examined.  On January 23 , I developed swelling and pain went underneath my armpit it?s a burning pain that?s constant since the third day after my injection. My blood pressure was 153/104 and I was having nausea and not feeling well at all. On January 25 the pain and swelling were still there I went to work for a few hours and I went to the emergency room. They gave me lidocaine patch and Zofran for the nausea my blood pressure was 159/103 and I had an ultrasound to rule out a blood clot there was no blood clot but there was lymphadenopathy under my arm hurt and swelling and inflammation around the shoulder. The chest x-ray showed left pleural effusion / Pneumonia. My oxygen saturation was 93 and they wanted to admit me but I am a single mom with a new diabetic 14-year-old at home so they let me go home with a pulse oximeter and a prescription for doxycycline For 10 days.  They called me the next day from the emergency room to follow up with a pulmonologist and cardiologist. On January 28 I saw the pulmonologist who did an ultrasound in his office and saw the fluid on my left lung. He said that most likely because the technique of the injection was so high in my shoulder that they probably had a nerve and I did have the swelling in the lymphadenopathy and all the pain and it hurt when I breathe so I wasn?t breathing correctly and I was splitting my arm against me and that?s how I probably developed plural effusion and pneumonia. I am following up with him on February 4. I still have shortness of breath and my oxygen saturation is 93. I am also on two inhalers that the pulmonologist ordered.
had a serious operations and infection; Operation; have the first dose in 2018; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced infection (serious criteria other: serious by reporter), operation nos and incomplete course of vaccination. On an unknown date, the outcome of the infection, operation nos and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the infection and operation nos to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in 2018 and had serious operation and infection. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The patient enquired if he/she could take second dose of shingles vaccine.
pt c/o rxn to anthrax inj;pt stated n rxn p/first shot;burning, swelling, tender muscle for 2 wk p/2nd shot;arm turned black & blue @ inj site (lt arm) p/3rd shot;no sx now;
lingering cough; tested positive after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (lingering cough) and COVID-19 (tested positive after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (tested positive after first dose). On an unknown date, the patient experienced COUGH (lingering cough). At the time of the report, COUGH (lingering cough) and COVID-19 (tested positive after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphur drug" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid from 13Aug2023 to 17Aug2023 as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After receiving Flu vaccine, pt become flush and diaphoretic, dizzy, and complained of tingling in fingers bilaterally. Pt was given an ice pack. Vitals signs were in within normal limits. Pt was observed for 20 minutes. No signs of breathing difficulty, No rash, symptoms improved. Pt was taken to urgent care center via wheelchair for further assessment.
Approximately a week after vaccine, I began to have Claudication pain in right leg that progressed to critical limb ischemia with 4 weeks requiring surgery to remove serial clots in right lower extremity.
2/16/17 Employee at hospital contacted "will not hurt her, mother notified of s/s to watch patient for - verbalized understanding. 2-27-17 Mother stated patient had fevers (103 F) day 8, day 9, and day 10 after immunization, then temp's went to 94 F. (Previously had rxn to DTaP May 2015.)
"A nurse reported that a 4 month old male received Rota Shield, Acel-Imune, HIB-TITER and IPV vaccines on 7/14/99 and subsequently, developed 2 to 3 episodes of diarrhea daily. On 7/24/99, he experienced colic."
Swollen lymph node in left armpit area that is very painful. This is the same side my moderna booster shot was given.
Swelling of the left arm, itchiness on arm and body. I took benadryl , ibuprofen, and ice pack on arm
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified. Follow up information was received on 04 April 2008 via a nurse, who reported that the subject  was a 70-year-old female, who received her FLULAVAL vaccination in her left arm. The nurse reported that the onset date of the adverse events was 11 December 2007, and the events were resovled as of 15 December 2007. The reporting healthcre professional considered the events to be related to vaccination with FLULAVAL.
This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. This consumer reported similar events for herself and her husband. This is the second of two reports. A male patient of an unspecified age, gender and race received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced vaccination site stinging (major stinging after receiving pneumococcal 13-val conj vac (dipht crm197 protein)). Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017142823 Same reporter/product/event, different patients.
Moderna vaccine x 2. Tested positive for COVID 19 on 2/1/2022. Admitted to Hospital  on 02/09/2022. Expired on 03/07/2022 while still hospitalized.
Pt stated she received the PREVNAR vaccine in her right arm on 10/1/2018 and later that evening "blood leaked into arm, pain radiated up from arm to neck and head." She stated about 7 days after the vaccine she suffered from headaches, high blood pressure, low energy, tired, sick feeling and it has completely changed her life. She said she had to be put on blood pressure medication from this. Her doctor prescribed her blood pressure medication on 12/10/2018.
Hospitalization within 6 weeks of receiving the first COVID vaccine dose. Second dose received 4/7/2021.
prolonged diffused pain associated w/hepatitis b inj;pt exp decreased ROM d/t possible joint and/or muscular pain;
Eleven days after receiving the dose, he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Eleven days after receiving the dose, he died) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Feb-2021 The patient died on 21-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Unknown          Action taken with mRNA-1273 in response to the event was not applicable.  Prior to the patient's receiving his first dose of the Moderna Covid-19 vaccine series, wife reported that he was hospitalized for Covid-19 infection for three weeks. While hospitalized, he was treated for Covid-19 infection with medications unknown to her and was very sick on a ventilator in the ICU. He was then discharged to a rehab facility for several weeks and moved to a nursing home for additional rehab. Eleven days after receiving the dose, he died on 21 Feb 2021. He had been getting along well and working on coming home prior to receiving the first dose.  Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death