chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of vomiting blood in a 2-month-old male patient who received PEDIARIX. Co-suspect products included ROTARIX. In 2015, the patient received PEDIARIX and ROTARIX (oral). In 2015, 30 min after receiving PEDIARIX and ROTARIX, the patient experienced vomiting blood (serious criteria GSK medically significant). On an unknown date, the outcome of the vomiting blood was unknown. It was unknown if the reporter considered the vomiting blood to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: The patient also received other non-GSK vaccines (not further specified) along with PEDIARIX and ROTARIX. About half an hour after receiving the PEDIARIX and ROTARIX, the patient experienced blood in vomit. The patient visited emergency room, but he was not kept there.
slight bump in my arm where I received the vaccine; It is also slighty tender to the touch; This is a spontaneous report from a non-contactable consumer.  A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown.  The patient reported that 'last night' she noticed that there was a slight bump in her arm where she received the vaccine. It was also slighty tender to the touch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna Booster RT deltoid @ 2:30 pm on thurs 12/30/2021  NO PRIOR ADVERSE RXN TO VACCINATION #1 05/12/2021 #2 06/08/2021.   First symptom 0330 on 12/31- generalized aching, severe upper body,  And headache                                                  Legs better by mid day; upper  Body myalgia persisted----" felt like hit with baseball bat, never felt like that" 11 am Friday developed " instant chest pain over left breast about 2 in medial /superior to nipple with a palpable nodule size of "walnut" 1840 pm developed pain in right axilla, HAD A tender & LARGE "SOFBALL SIZE" lump WITH ERYTHEMA, then to ER ON Saturday 1/1. Erythematous rash with tiny papules developed in a large area to back and along the anterior axillary area. At ER MASS MEASURED 3 IN w x 4 IN Length. Rash was well beyond those parameters.  Mild Tenderness in infra-axillary region persists. Sunday 1/2 developed erythema at injection site and axillary rash worsened. LFTS ELEVATED BEYOND BASELINE   This has been followed up by Dr, ER physician by phone.
Acute local reaction to immunization. Pt thigh swollen after 4 mo. immunization this morning. Rt thigh swollen and red. Doctor said to give patient Tylenol for pain or fever. Pt was crying with pain.
I started feeling a scratchy/sore throat around 1h30min after taking the 3rd dose, which gradually worsened throughout the day. In the evening, the pain became very intense, and my throat felt swollen. I woke up at night feeling like my throat might close, but I was still able to breathe. I woke up at a different point choking on my own saliva, and coughing profusely as a consequence. Today upon waking up my throat was red and looked somewhat swollen; my uvula in particular looked somewhat edematous (perhaps the soft palate as well, but I could not tell).
Patient self-reports previous COVID-19 infection in January 2019 with subsequent COVID-19 vaccination via a 2-dose series which he states was completed in early April 2021. No records to indicate the manufacture, vaccination dates or the lot numbers. Patient has since been diagnosed with COVID-19 reinfection on 5/1/2021. Covid-19 case report submitted via Electronic Disease Surveillance System.
Told to include this information in this box: Janssen COVID-19 Vaccine EUA  Symptoms: Fatigue, nausea, body aches (entire body, but especially hips and injection site), and temperature between 98.5F-99.8F all day on the first day following the day of injection. Tylenol taken once and Advil taken twice throughout the day, which mostly relieved symptoms. Second day following day of injection, moderate fatigue in the afternoon, even after full 8 hour sleep with CPAP on all night.
This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist gave a patient a second dose at 20 days instead of 28 days) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist at the Walmart gave a patient a second dose at 20 days instead of 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pharmacist gave a patient a second dose at 20 days instead of 28 days) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. NO CONCOMINANT AND TREATMENT DRUGS WERE USED. Patient doesn't have any complication from vaccine. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-may 2021: added to narrative and event outcome changed to recovered.
Patient reports 1 hour post vaccination symptoms: jittery, feeling lousy. 12/18/20 Am reported bodyaches, red/watery eyes, chills, and blurred vision. States she can see better in dark than in bright lights. Previously hx of COVID 19 illness November 2020. Took Tylenol and Allegra 12/18/20. Reports improvement in symptoms 12/18/20 12:40pm but continues to report mild blurred vision. Advised to seek immediate medical care if condition not improved or worsens.
3 days after second dose, right arm red, hot and itchy from injection site to elbow.  Saw personal doctor 2/26/2021.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L016283, expiry date: 07-AUG-2016) (incorrect product storage). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1511USA012683 (same reporter link). Additional information has been requested.
Staff member reported nausea, vomiting, chills and extreme malice-symptoms subsided within 72 hours, no treatment needed
At 1405, patient began c/o headache with a 9/10 pain level.  Patient had been waiting approximately 30 minutes post-vaccination due to previous reaction to flu vaccine.  Vital signs were taken by MSN RN and EMT  at 1405 with BP of 179/98, HR 72 and O2 Sat of 95%.  Patient also stated that "her throat felt like something was stuck in  it like indigestion".  Patient also states that she took 1000 mg of Tylenol at 1200 with food prior to vaccination.  At approximately 1430, a second set of vital signs were taken with BP 179/89, HR 73, and O2 sat of 95%.  Patient was offered and accepted ambulance for further evaluation.  Due to increased BP and HA, patient was then transported to Regional Hospital for further evaluation.
Systemic reaction of Hives/Rash on Left and right arm, left and right legs, abdomen and back.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult white male of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-AUG-2021, the patient got sick and developed Covid after receiving the Covid-19 vaccine, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210835110-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I experienced arm pain that continued after my vaccine for an extensive time and up until today. I am in physical therapy. I still have limited use of my arm at this date 8/16/2023. The pain gets worse when i am sleeping. It's excruciating. Should down the back of my arm down to the elbow. MRI prescribed 1 valium for claustrophobia for the MRI, and Aleve for the pain. When I went for the MRI results the Dr prescribed me voltaren gel helps the pain, 4 times a day on the joint in my arm. It does help.
Pt experienced redness, pain, swelling and warmth on left upper and lower arm, the night of the injection. RN was notified the next morning. Instructed pt to take ibuprofen and consult MD. On 12/18/00, she saw MD and was dx'd with cellulitis and placed on Keflex. Contact made on 12/20/00 and condition is much improved.
Initial unsolicited report received from a consumer (Patient's sister) via other company, Pfizer (Reference number-2017074827) on 07-Mar-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DTP) (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unknown day of 1983 (reported as six month dose). The medical history and concomitant medications were not reported. On an unknown day of 1983, three hours of following the vaccination, the patient developed seizure and it caused the patient to be mentally and physically handicapped, the patient never walked and talked. "The patient was like an one year old in the body of a 13 year old". The laboratory test and the corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event seizure. List of the documents held by sender: none.; Sender's Comments: Patient received DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (Mfr Unk) following which patient had seizure within 3 hours, mentally and physically handicap and patient never walked and talked. Time to onset is compatible, but additional information regarding patient's medical history, concomitant medications and past vaccination and its tolerance are needed to further assess the role of vaccine. Based on available information the role of vaccine cannot be assessed.
Client received Covid vaccines on 2/21 and 3/15/2021 in another country.  Client does not know the name of vaccine she received other than it was the Covid vaccines.  Developed symptoms on 8/28/2021 (fatigue, loss of taste and smell), and tested positive PCR for Covid on 8/29.  Reported as a case of breakthrough Covid in a previously vaccinated person.
Woke up on the floor, not sure if passed out or was unconscious; Cramps in hand; Hands shook; Dry heaving; Voice kind of changed; Urine was very bright; Chills; A spontaneous report was received from a female (age unknown) consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious.  The patient's medical history was not reported. No relevant concomitant medications were reported.   On 28 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, patient started to experience cramps in hand, shaking of hands, dry heaving, voice kind of changed, urine was very bright, chills and woke up on the floor, not sure if passed out or unconscious. Treatment for the events were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, cramps in hand, hands shook/shaking of hands, dry heaving/dry heaves, voice kind of changed/distorted voice, urine was very bright/urine color abnormal, chills and woke up on the floor, not sure if passed out or unconscious was Unknown.; Reporter's Comments: The events developed after first dose of mRNA-1372. Very limited information regarding this events has been provided at this time.  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.
Vaccine breakthrough, asymptomatic.   Inpatient admit 9/2-9/5.
Initial unsolicited report received from a consumer on 06-Sep-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer unknown batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. The patient's medical history, ongoing illness and risk factors were not reported. On unspecified date, following the vaccination patient had a reaction to a flu vaccine. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
Bad sweats on the 3rd night; Heavy metallic taste a few hrs after the vaccine/became increasingly heavy the next day which lasted two days; I needed up bad aches for 24 hours the day after; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Bad sweats on the 3rd night), DYSGEUSIA (Heavy metallic taste a few hrs after the vaccine/became increasingly heavy the next day which lasted two days) and MYALGIA (I needed up bad aches for 24 hours the day after) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Bad sweats on the 3rd night), DYSGEUSIA (Heavy metallic taste a few hrs after the vaccine/became increasingly heavy the next day which lasted two days) and MYALGIA (I needed up bad aches for 24 hours the day after). At the time of the report, NIGHT SWEATS (Bad sweats on the 3rd night), DYSGEUSIA (Heavy metallic taste a few hrs after the vaccine/became increasingly heavy the next day which lasted two days) and MYALGIA (I needed up bad aches for 24 hours the day after) outcome was unknown.            No treatment medication were reported.
PATIENT CAME IN AND SAID HE COULD BARELY LIFT HIS ARM THE NEXT DAY AFTER GETTING THE SHOT.  VERY TENDER/SORE TO THE TOUCH.  UNDER THE ARM WAS SWOLLEN AND RED.  HE ALSO STATED HIS LOWER ARM VEINS HURT AND ALSO BY HIS NECK.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient stood up after receiving covid vaccine, took 3 or 4 steps away from pharmacy and fainted and fell on floor.  patient came to within 5 seconds and was responsive to all of my questions.  we then had him seated for 20 minutes until he no longer felt lightheaded or dizzy.  i took his BP and it was 100/69 with HR of 72.  followed up with patient via phone and he said he is fine.
This case was reported by a physician via an OSHA safety officer and described the occurrence of influenza symptoms in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 8 April 2011 the subject received 1st dose of ENGERIX B at 0.5 ml, intramuscularly, in the right arm. On 8 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced severe influenza symptoms and developed a large, hard, area on her arm (hard spot at injection site and injection site redness). On 20 April 2011, the events were resolved. The physician considered the events were probably related to vaccination with ENGERIX B. Follow-up information was received on 03 May 2011. It was confirmed that the events resolved and were not considered to be serious. The reported stated that the subject did have a cold on the day of vaccination with ENGERIX B with sore throat, shortness of breath and lightheadedness from 08 April 2011 and ending 13 April 2011. The second dose of ENGERIX B was scheduled for 09 May 2011.
Skin burns on left flank near abdomen and buttock on the same side as the injection was administered on my arm. Neuralgia like symptoms. Also experienced by my wife in the same area who had her injection administered on the same side at the same time as me.
seen @ clinic w/temp 103.3 ax;tx w/Rocephin;seen by MD & ped consult;seen @ clinic 9AM 5FEB98;temp 101.5 ax rocephin given; seen in ER 5FEB98 714PM temp 98R sz;sent to hosp for sepsis r/o meningitis;
Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Skin started to blister, after blistering, pain stopped and itchy started; Skin started to blister, after blistering, pain stopped and itchy started; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 26Apr2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sparse migraines and periodic back pain. The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8133) via an unspecified route of administration in the right arm on 05Apr2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 06:00, the patient experienced rash on both hands, left hand more severe and splotchy red marks, about 4 in total. It was reported that main rash on left hand hurt and throbbed and skin started to blister, after blistering, pain stopped and itchy started. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed and skin started to blister, after blistering, pain stopped and itchy started was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Injection site warm to the touch; The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine; The fingers of the left hand started swelling and almost had to have the wedding ring cut off; Joints are swelling; The injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE BRUISING (The patient said it spread from the injection site and there was a bruise/The area was the size a tangerine), PERIPHERAL SWELLING (The fingers of the left hand started swelling and almost had to have the wedding ring cut off), JOINT SWELLING (Joints are swelling) and VACCINATION SITE ERYTHEMA (The injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
patient came in 1 week early for booster and this was not caught prior to vaccine being administered
I had SHINGLES after the first dose. Started having back pain about 25 hours after receiving the first dose. Pain continued to worsen over the next 3 days. On January 31, 2021 I had aching pain in my back and sharp stabbing pain in my stomach,  nausea, headache, light fever, and extreme fatigue. On February 1, 2021 I had a rash on my left side front and back around my rib cage. Later that day I learned I had SHINGLES.
COVID 19; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: en9581), in right arm, on 20Feb2021 as dose 2, single (Lot number: el9267), in left arm and on 01Sep2021 as dose 3 (booster), single (Lot number: fd8448) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient had no other medication received within 2 weeks. On 19Apr2022, patient had received covid-19 treatment Paxlovid until 24Apr2022. Adverse event tested negative on 24Apr after completing 5 day dose of Paxlovid. On 30Apr2022 had sore throat, stuffy nose. Tested positive for covid.