chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 5/18-Moderna dose 1 6/15- Moderna dose 2 7/16- Six first started with cough and sore Throat 7/26- COVID positive, family member also positive 7/28- reports mild nasal congestion 8/4- SOB at night, inhaler not helping much, nebulizer ordered.
one month later I had chest pain and severe shortness of breath with low grade fever, lasting three days.  Tested negative twice for covid.  I continue to have minor chest pain.  (After the second shot I had chills and low grade fever for 24 hours..nothing much)
Fever of 103.0 x 1 episode. Stiff for a few seconds. Chills.
This case was reported in a literature article and described the occurrence of tetanus in a 17-year-old male subject who  was vaccinated with Diphtheria tetanus acellular pertussis, manufacturer unspecified). The subject's ethnicity was stated and he was homeschooled at the time of the event. On 26 June 2012 he had stepped on a rusty boat anchor and sustained a puncture wound to his foot while working outdoors for a sailing program. He had cleaned the wound with hydrogen peroxide. He had experienced mild pain but no local erythema, swelling or drainage from the wound. No further information on his medical family history or concurrent medication is available. On an unspecified date, the subject might have received an unspecified dose of Diphtheria tetanus acellular pertussis (administration site and route unknown, batch number not provided) during childhood. However, there was no record of him receiving any vaccination in his school, primary care physician's office or in the state immunisation registry. On 30 June 2012, at an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced tightness of neck muscles and jaw. The symptoms had worsened during the day and he had developed pleuritic chest pain too. The subject was hospitalised for 5 days. No details of any laboratory tests or diagnostic procedures have been provided. Diagnosis was tetanus infection. Initial treatment consisted of wound cleaning and administration of 250 U of human tetanus immune globulin, tetanus toxoid vaccine, and 500 mg of metronidazole. He was then transferred to a tertiary medical centre where he received 2 mg of lorazepam and was admitted to the general paediatric ward. During his hospitalization there, he received 500 mg of metronidazole every 8 hours for 5 days and an additional 6000 U of human tetanus immune globulin. Outcome was complete recovery with discharge from the hospital without sequelae on 4 July 2012. The author's conclusion stated that because immunization rates among homeschooled children are largely unknown, this population might be considered at higher risk for contracting more prevalent communicable vaccine preventable diseases.
Urticarial, erythema type rash of the trunk & extremities; pt was already on daily CLARITIN. Also took BENADRYL and PEPCID which seemed to help. Per pt rash was greatly diminished at her visit on 11/4/16.
Increased blood pressure from Pfizer Covid vaccine reported to Dr October 20, 2021 at office visit. September 15, 2022 prescribed amlodipine 5mg by Dr.
10.20.2022 PATIENT CAME IN FOR DIZZINESS, WEIGHT LOSS, AND ABDOMINAL PAIN IN RIGHT UPPER QUADRANT. PATIENT WAS ADMITTED AND HAD A LAPROSCOPIC CHOLECYSTECTOMY.
Pt states injection site very painful then developed large "bruise" on back of (L) hand. Arm is still sore 10d after injection. Visited ER- given NSAIDS. Bruise now diffusing
Day 1: Fatigue, severe chills, feverish, pain at site, muscle/body aches Day 2: Nausea, fatigue, muscle/body aches, puffiness Day 3: Fatigue, redness at site, swelling at site, glassy eyes
Right hell swelling, redness, tenderness first noted on awakening 4/27 (3 days post vaccine).  Swelling a bit decreased when seen 1500 on 4/27.  No fever.  Mild pain when walking.
ActHib powder was mixed with a Pentacel liquid component instead of HIB component of Pentacel and administered, no AE; Initial information received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six-month-old patient who received third dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ146AAA and expiration date: 14-Feb-2021) where the liquid component (lot number U6314AB and expiration date: not reported) was reconstituted with HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ1188AB and expiration date: 07-Dec-2020) in place of HIB component (lot number UJ146AA and expiration date: not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on 29-Jul-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that physician when reconstituting Pentacel vaccine, a HCP used a stand-alone ActHIB lypolized powder vial rather than the HIB component of the Pentacel co-pack.  At the time of this report, no adverse event was reported.  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 and Module VI of the 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.
Information has been received from a physician concerning an around 60 year old patient who on approximately 29-AUG-2008, "1 week ago", was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 31-AUG-2008, "2 days after ZOSTAVAX (Oka/Merck) was given", the patient developed shingles-like rash.  The patient contacted the physician and was started on anti-viral medication and the rash was starting to improve.  Additional information has been requested.
10 days after first shot experiencing a rash, swelling, pain, and itching at the injection site, as well as, hardening skin
This spontaneous report was received from a registered nurse via company representative and refers to a 14 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date in June 2018, reported as "the last week", the patient received a dose of GARDASIL 9 for prevention of human papillomaviruses (HPV) related cancers and diseases (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient fainted, immediately after receiving the GARDASIL 9. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the event syncope was unknown and the reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA004955.
flu both times; Initial information received on 25-Oct-2020 regarding an unsolicited valid serious case received from a consumer via social media.  This case involves male patient (unknown age) who experienced flu both times (influenza), while he received two shots of INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a two dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu both times (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient (unknown age) who had influenza, after and despite vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, immune status and lab data excluding predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
7 patient's that received a delayed shipment of Fluzone Quadrivalent injection/no ae; 7 patient's that received a delayed shipment of Fluzone Quadrivalent injection/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311020, 2019SA311015, 2019SA311022, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 44 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30Jun2020, Box: Lot UT6713KA, Exp. Date: 30Jun2020) on 04-nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with anti-viral Paxlovid from 27Jul2022 to 31Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Back part of tongue is sore; lips swollen; Nose and lips swollen; Rash on both arms; itchy rash on both arms; Itchy fingers; Red faced and red hands; Blisters on lips; Blisters on outer nose; Blisters on lips and bleeding also; Red faced and red hands; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A 60-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 at 13:00 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE (at the age of 60-year-old) for COVID-19 immunisation. Medical history included High blood pressure, borderline cholesterol being high and COVID (covid prior vaccination) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 20May2021 at 13.00 (Batch/lot number: ER8727, in left arm) for covid-19 immunisation. The patient previously took Lipitor (Some statins. etc. Lipitor) and experienced Known allergies. No other vaccine received in in four weeks. The patient received unspecified other medications in two weeks. On 10Jun2021 at 18.00, the patient experienced nose and lips swollen, rash on both arms, itchy fingers and itchy rash on both arms, red faced and red hands, blisters on outer nose, blisters on lips and bleeding also and back part of tongue was sore. The event caused Physician Office Visit. The patient not tested for covid post vaccination. The patient received unspecified treatment for events (Meds from nurse practitioner). Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered.   Follow-up attempts are completed. No further information is expected.
A report was received from a health care professional on 2/4/04 concerning a female vaccinee of approximately 72 years of age who experienced a sore throat, flu-like symptoms and bilateral lower extremity weakness after receiving Fluvirin on an unspecified date in October 2003. The vaccinee had a previous history of neuropathy in her feet. On an unspecified date in October 2003, the vaccinee experienced a sore throat in the evening after receiving Fluvirin. A few days later, the vaccinee developed mild flu-like symptoms. At the time of the report, the vaccinee was experiencing bilateral lower extremity weakness which was greater in the right than in the left. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Headache, Arthralgia, Lethargy and tinnitis Narrative:  Other Relevant History:
Relapse of Parsonage Turner syndrome  , I was symptom free for 2 years before my vaccination
ADMINISTRATION ERROR: 12 YEAR OLD FEMALE PATIENT IS VACCINATED WITH THE BOOSTER DOSE OF THE PFIZER VACCINE. THE BOOSTER DOSE OF THE PFIZER VACCINE IS AUTHORIZED FOR PATIENTS AGED 16 AND OLDER ONCE THE 6 MONTHS OF THEIR SECOND DOSE.
pt became pale, diaphoretic & clammy;BP 80/50;cap refill <1sec;02 via mask;seemed to be vago vagal response;
I have had no adverse reactions until last night. The injection sight is now red, raised and warm to the touch.
soreness of the arm; swelling and heating on the arm; swelling and heating on the arm; small blisters on her mouth; This is a spontaneous report from a contactable physician received via Pfizer-sponsored program. An 89-year-old female patient (reporter's mother) received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received Prevnar vaccine about 8 years ago and 8 days after receiving the Prevnar vaccine, she experienced soreness of the arm, swelling and heating on the arm and small blisters on her mouth. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected. Information about batch number cannot be obtained.
After administering the vaccine, the patient lost consciousness for less than a minute.  She has a history of syncope with vaccinations.  We provided the patient with water and she sat for about 20 minutes before her father drove her home.
Breakthrough case admission after 4 vaccines  Moderna 4/20/21 Lot# 017B21A;  Moderna 5/18/21 Lot# 006C21A;  Moderna 12/16/21 Lot# 078J21A;  Moderna 6/9/22 Lot # 014B22A
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an multiple unspecified dates, the patients were inadvertently administered improperly stored doses of VARIVAX lot numbers M033212 and M032358; expiration dates 13-JUL-2018 and 05-JUL-2018 respectively (dose, route of administration and anatomical location were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of VARIVAX were exposed to a temperature excursion of 5°C for 2 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
This case was reported by a physician and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included Hib (manufacturer unspecified), IPV (manufacturer unspecified) and PREVNAR (PFIZER) all given on 18 April 2011 while in a foreign country. Concurrent medications included Paracetamol (given just after vaccination). On 18 April 2011 while the subject was in a foreign country, she received 1st dose of INFANRIX at 0.5 ml in an unknown thigh. One and a half hours following vaccination, the subject was crying unstoppably for greater than three hours until she fell asleep. During that time the subject was unable to eat "due to crying" even though she was hungry. After a nap, the child was still irritable and unable to eat properly. It was noted that crying and inability to eat ended the following day, 19 April 2011. Outcome of irritability was not stated.
right side of neck feels like slept on it wrong; right side of throat hurts to swallow; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 11:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa based drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from unknown date for an unknown indication and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 19:00, the patient experienced right side of neck feels like slept on it wrong and right side of throat hurts to swallow. It was reported that injection was given in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right side of neck feels like slept on it wrong and right side of throat hurts to swallow was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VERY BAD REACTION; SWEATS; SWOLLEN LYMPH NODES IN NECK; SWOLLEN HANDS AND WRIST SWOLLEN LIKE ARTHRITIS; SWOLLEN KNUCKLES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very bad reaction, sweats, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the sweats, headache, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles and very bad reaction was not reported. This report was non-serious.
Flu like symptoms; Sinus headache; Nausea; Injection site arm aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included GABAPENTIN, BACLOFEN, PANTOPRAZOLE, ESCITALOPRAM, RIVAROXABAN, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches) outcome was unknown.
muscle aches beginning with shoulders and neck before spreading over entire body; low-grade fever of 100 degrees, chills, nausea- all lasting for about 24 hours
This spontaneous report as received from a pharmacist refers to a patient of an unknown age. On 16-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N011305 for prophylaxis. On 16-AUG-2017, the patient experienced product leakage and accidental underdose. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA008021:
Red, swollen arm, and left thigh pain. She walks 3 miles/ day and never has pain, now 3 weeks after shot has left thigh pain. Her red swollen arm is the same arm as received shot and is improving each day.  I advised to place ice and call dr if worsens.  Just called patient today and she doesnt have any residual thigh pain and arm is recovered.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm) and fatigue (fatigued/felt tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 045C21A and 013L20A) for COVID-19 immunization. No medical history reported. On Jan 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (sore arm) and fatigue (fatigued/felt tired). At the time of the report, myalgia (sore arm) and fatigue (fatigued/felt tired) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-365820, MOD-2021-365923 (patient link).