chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4th dose of Covid Vaccine; 4th dose of Covid Vaccine; totally exhausted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "4th dose of Covid Vaccine"; FATIGUE (non-serious), outcome "unknown", described as "totally exhausted".  The lot number for bnt162b2 was not provided and will be requested during follow up.
several days after receiving the shot I developed cellulitis at the injection site.  The area has been increasing and is now approximately the size of a credit card.  Pink, warm, hard and slightly itchy.  I have not treated it.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 24th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, fever and injection site warmth. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site swelling was unchanged and the outcome of the fever was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, fever and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX via subcutaneous route, which led to inappropriate route of vaccination. The physician visit was required for swelling which had not improved.
Dizziness; Palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from Aug2019 to an unknown date (Has had a Mastectomy, she doesn't know if the cancer is still there or not), Microbacterial infection in the lungs from Sep2018 and ongoing. Concomitant medications included alprazolam (XANAX) taken for anxiety from Jun2020 and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken as her stomach is a huge problem for her (Stomach Acid) and ongoing. The patient asked if she could get her second scheduled vaccine while having symptoms of palpitations and dizziness. She stated she has had palpitations before but these palpitations after the vaccine started on 10Mar2021 (7 days after receiving vaccine). She said she had been a little bit dizzy since her shot but a little bit more today. She had her first shot on 03Mar2021 and her second is scheduled for 24Mar2021. She would like to change her appointment for her second dose and see how she feels. She clarified the dizziness started yesterday and she does not think it's getting worse. Caller stated she had an ultrasound in Jul2020. She had treatment for palpitations prior but confirms she has not had treatment for the palpitations she experienced after the vaccine. Additional vaccines were not administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) were taken. The adverse events did not required visit to emergency room nor physician office. The outcome of the events was not recovered.  No follow-up attempts are Possible. No further information is expected.
bad allergies; nose is running; sneezing; This is a spontaneous report from a contactable consumer (patient). A unspecified age of female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 25Jan2021 at 15:30 as a single dose for COVID-19 immunisation. The patient medical history was not reported. concomitant medication included Flonase. On unknown date the patient experienced; the caller stated she works in the medical field in support services as an equipment specialist. She stated she had the second dose of the vaccine this past Monday, less than 48 hours ago, at 3:30 PM. She stated she has had bad allergies her nose is running, and she has been sneezing. She stated she usually takes Flonase, a glucocorticoid, which is a steroid and she used it and immediately after was worried about the vaccine. She rinsed her nose with saline but asked if this can effect the vaccine. The caller stated she had filled out a survey that asked if she had a headache and other symptoms but know if those were things to include. She stated she called her mom who lives in (state name withheld) and she said hadn't even thought about it but her nose was running yesterday too, and the caller's co-worker said he got a cold for the day. The caller stated she did not want to disclose any information about them. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
The diluent used for the Yellow Fever Vaccine had expired on 6/21.  The patient reported no adverse effects.  She has been advised to return after 28 days for a valid dose.
Information has been received from a health professional concerning a 16 year old female pt who in November 2002, was vaccinated with a dose of hep B virus vaccine (642248/0003M) and was subsequently vaccinated again in November 2002 with a dose of hep B virus vaccine (8388M). Several weeks later in approximately December 2002, the pt "broke out" with a rash. Unspecified medical attention was sought. Additional info has been requested.
Patient said she developed nausea/vomiting. Her vomiting worsened 6/29/20 and she went to ER to get treated.  Patient  said ER doctor found underlying gallstones that patient was unaware of and she said doctor thought the vaccine may have aggravated her condition.
Information has been received from a nurse concerning a 5 year old male who on 17-May-2005 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant therapy included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) tetanus toxoid and a dose of poliovirus vaccine.  On 17-May-2005, the patient developed hives.  He was treated with diphenhydramine hydrochloride (Benadryl) at the ER and released.  He was also referred to an allergist.  Subsequently, the patient recovered.  No product quality complaint was involved  Hives was considered to be an other important medical event (OMIC).  Additional information has been requested.
Patient c/o temperature of 101 the night after her vaccination.  Patient also c/o of shortness of breath for 30 or 40 minutes the evening after vaccination.  Patient stated symptoms resolved the following day.
half the dose was administered.; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 12-month-old male patient who received HAV (Havrix pediatric) (batch number 2k57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Havrix pediatric (intramuscular) .25 ml and Havrix Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The HCP reported that the patient did not get complete dose of Havrix, the patient was moving and the syringe came out when administering the dose, which led to accidental underdose. The HCP stated that approximately half the dose was administered. The reporter consented to follow up.
Fever; Headache; Swelling on armpits; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, Headache, Vaccination site pain and Lymphadenopathy axillary, at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: The follow-up  received on 11-May 2021 was significant and included 2 appended SD's. Follow-up additional I was a picture of the adverse event. Additional 2 was the reporting of the new event in a language other than English. On 20-May-2021: Follow-up additional 3 was the appended translation for the follow-up additional 2 SD.
Pt vaccinated with DTP experienced a fever of 104, irritability, lethargy and a prolonged cry within several hrs after immunization hospitalized on day 6 25FEB90. Dx as coincidental kawasaki disease.
High fever for 3-4 days of 101-103, severe chills and body aches, headache and severe diarrhea for 3-4 days, fever and chills resolved in 3 days, still with slight loose stools on 9/22/2022 when seen in clinic. Patient c/o when vaccine given, felt like her muscles in her arm were separating in two. Patient treated herself at home, but states that on day 3 after the vaccine thought she was going to have to go to ER for severe weakness and possible dehydration.
Onset swollen lymph nodes in right arm pit.  Now the complete bottom half of my reputation is swollen.
Diagnosed with COVID  on 9/22 and treated OP with antibiotics and monoclonal antibody infusion.  Admitted to hospital on 10/5 with increasing chest pain and shortness of breath. Abnormal EKG. Cardiology and Nephrology followed patient. COVID + on admission. Had cardiac arrest with 5 rounds of chest compressions and multiple meds. Family contacted and requested DNR so ACLS was terminated.
Pfizer-Moderna Interacction; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer-Moderna Interacction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
STARTED AS LOCALIZED REACTION. NEXT DAY Pt FELT FEBRILE AND ITCHING THROUGH ENTIRE BODY. WENT TO ER 3 DAYS LATER. NAUSEA & MUSCLE WEAKNESS. GIVEN BENADRYL 50mg Q6H
High fever over 103 deg which resulted to two focal seizures. The medical records received on 2/11/03 states final diagnosis was comlex febriel seizure. Additional discharge diagnoses included r/o sepsis, yeast infections of mouth and skin, and diarrhea. 60-day follow up on 02/10/04: "Pt has recovered from adverse events. Pt was given her 6 month immunizations in January. Her doctor decided to give her a DT shot instead of a DTAP in hopes that she would not obtain a fever, in which, she did not. I was advised to give her Tylenol and Motrin every 3 hours for 3 days after to prevent a fever.  I'm not sure if it was the change in the vaccine or the Tylenol/Motrin, but she did not develop any reaction at all. Thank goodness!!"
Pfizer-BioNTech COVID-19 Vaccine EUA: immediately after administration of vaccine patient experienced dyspnea, rash, chest pain, and flushing. Administered epinephrine, methylprednisolone, diphenhydramine, and famotidine. Transported to the emergency department: no evidence of airway obstruction or edema. Patient received an additional dose of diphenhydramine, admitted to the hospital, improved, and discharged to home medically stable.
Irregular heartbeat for approximately 5-8 minutes.  Light-headed during this time. Resolved on its own eventually.
unusually prolonged erythema @ Dt inject site (9 x 15 cms) lt upper arm 4 days p/inject;
Prolactin increased; Estrogen increased; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 22Feb2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient had her prolactin and estrogen increased and reported that her previous levels were normal. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events prolactin increased and estrogen increased were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I?m now on steriods. And got a shot with steriods in it. Since this pharmecy hit a nerve and went to high in my arm. Urgent care prescribed me.
Said has no sense of smell; This is a spontaneous report via Pfizer Sponsored Program. A non-contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2(Covid-19 Vaccine: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient just had 1st dose of covid vaccine. Said her side effects are different from ones listed in pamphlet. Said has no sense of smell. The clinical outcome of the said has no sense of smell was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
3 days p/inject of vax c/o diarrhea, stiffness in neck, sweating;
Aching flu like systems, chills, weakness, nausea, low grade fever, which lasted 4 days & injection arm was extremely sore for 7 days.
No reaction to vaccine. However, while clerk was going thru remits (12/19/2022( it was found that this patient had received 2 FLU shots this flu season. The first FLU shot was given during a drive thru flu clininc on 09/27/2022. The second flu shot was given in side the clinic on 11/18/2022.All of this information was relayed to the patient and he was let known that he did not need any more FLU shots this flu season.
This spontaneous report as received from a certified medical assistant (also reported as nurse) via a field representative refers to a 61 year old male patient. The patient's concurrent condition included diabetes. On 18-DEC-2014 (also reported as 18-DEC-2015) the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose (strength, route and lot number not specified). There was a failure with the needle syringe, resulting in the medicine leaking out and running down the patient's arm. The medical assistant and the physician were not sure if the patient got enough medicine so they re-administered a full dose of PNEUMOVAX 23. The patient was also given a flu shot, concomitantly in the opposite arm. On 15-JAN-2015, the patient went to the office complaining of arm pain. The medical assistant noticed mild redness on the arm as well. The patient sought medical attention - he was prescribed prednisone. The patient was still complaining of pain and had not been using his arm due to soreness (disability) and hence the physician recommended physical therapy. The patient had not recovered from the arm pain and redness in arm. Causality assessment was not provided. There was no product quality complaints (PQC) involved. Additional information has been requested.
Wed Mar 31 - day of shot Stiff neck on side of shot Sore arm on shot site Heavy period w painful cramps for two days   Swollen, painful lymph node in neck on same side as stiff neck and same side as shot - visit to chiropractor following day  where it was numbed with bengay type product and vigorously rubbed.  As of Saturday, Apr 10 pain and swollen lymph node still present but pain significantly less.
3/27 Light headedness, dizziness, faint @12:45 Light headed and dizzy along with panic Attacks on and off until 3:00pm Chest Pain accompanying panic attacks every 5-10 min until 3:00pm Nausea on and off with each light headedness  3/28 All Day Continued light headness, dizziness, and nausea. Only 2 panic attacks. Headache starts at 3:00pm  3/29 All Day Continued light headness, dizziness, and nausea
Patient states that by evening, injection site was swollen and red about size of half dollar. Felt very tired the day following the injection day.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 10-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route were not reported) (indication was default). No concomitant medications were reported. On 17-OCT-2014 the patient came to the pharmacy and stated that for an unknown reason on an unspecified date, she had titers drawn for PNEUMOVAX 23 and the titers came back as negative. The outcome of the event was reported as not recovered. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08May2021 10:30 (Batch/Lot Number: E100171) as 1ST DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included gout from an unknown date and unknown if ongoing, known allergies to latex. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after the vaccine on 09May2021 at 06:00 AM, patient developed a cough. It went into his lungs within a couple of days and was eventually put on strong antibiotics with a lung infection. His lungs hurt when he breathed, patient had shortness of breath. It's currently 20May2021 and patient still had pain when he cough but it seems to be improving. The events resulted in Doctor or other healthcare professional office/clinic visit. Events treatments included an inhaler, antibiotics, cough pearls. Covid test post vaccination included Nasal Swab COVID 19 test on 18May2021 and the result was pending. Patient was not recovered from events.
High fever, chills, extreme pain in all joints and muscles, especially legs, knees and ankles; dizziness, headache.
I experienced shortness of breath and heart palpitations the emergency room EKG was abnormal but additional heart monitoring showed benign atrial tachycardia.
No further AE details; HCP called to report that a dose of VAXNEUVANCE that experienced a TE on 9/6/2023 that was Not Supported was administered to a patient on 9/7/2023. HCP gave permission to contact. No further AE details/ No PQC.   ?; This spontaneous report has been received form a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 06-SEP-2023, a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot number: X011332, which was determined to be valid, with an expiration date on 01-JAN-2025) underwent a temperature excursion of -0.55 degrees Celsius for 5 hours, which was not supported.  On 07-SEP-2023, the patient was vaccinated with the improperly storage dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, at a dose of 0.5 milliliters once as prophylaxis (strength, route and anatomical location of administration were not reported).  No previous temperature excursion was reported.  No additional adverse event was provided.
Round raised rash at injection site lasting 14 days Fever at injection site lasting 5days Swollen lymph node on left side of neck under chin appearing 7days after injection to now Swollen lymph node on right side of neck under chin appearing 14days after injection to now