chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered 2nd dose and had been sitting for approximately 10 min. Patient described feeling sick and started dry heaving. No vomiting, patient then reported throat tightening and feeling itchy, but did not have trouble breathing. Patient reported feeling better within a few minutes, husband gave benadryl but reported being difficult to swallow, and she relaxed for another 10-15 min. Asked patient to stay longer but insisted she was okay now except for an itchy throat and they left about 25 min after injection.
Lymph nodes in neck swelled rapidly to include my face in front of my ears both sides but right side much worse
kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.
upper lip starting to swell; discomfort of lip; Numbness of lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 29Mar2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and cholesterol medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced upper lip starting to swell, discomfort of lip, and numbness of lip on 31Mar2021 at 07:30. It was reported that the upper lip swelling was noticed during breakfast and throughout the day, it got increasingly worse. There was no pain, just discomfort and numbness. The patient did not receive any treatment as a result of the events. The clinical outcome of upper lip starting to swell, discomfort of lip, and numbness of lip was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
sore arm; more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "more tired".  Additional information: Caller queried and asked what side effects can patient get from the Pfizer-BioNTech COVID-19 vaccine, which professional would give her the Pfizer-BioNTech COVID-19 vaccine, also if pharmacist can give the vaccine, how does the vaccine work, what was in the Pfizer-BioNTech COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Angioedema to the lips, painful ulcerations on the tongue and ulcerations to the posterior oropharynx starting 4 days after the flu shot. Also with 3 mm erythematous macules on the palms. Large local reaction at the shot site and small bullae in the inferior aspect of the shot site on left upper arm. Rash most consistent with erythema multiforme. Additionally she had completed a course of BACTRIM a few days prior to the flu shot and prior to rash development.
Complaint of feeling dizzy, chills, difficulty breathing through nose, weakness.  Took Benadryl, felt relief afterwards.  One day later patient felt stiff and lightheaded, then symptoms subsided.
Immunizations given (Hib in upper RVL, Prevnar in lower RVL) Injection sights were cleansed with alcohol and aspiration done prior to injection of vaccine.  It was noted that both sites bled more then the usual infant injection would.  On 1-13-09 mother called to report child cried for 2 hours after shot and within the next 24 hours child had vomited X1, ran temp (not over 100) injection site red, swollen and child wold not straighten leg.  Mother said child is fine now with the exception of a small (pencil eraser size) bruise. Mother also reported child having nose bleeds 2 to 3 weeks.
Sharp upper back pain that radiated into chest. Pleuritic in nature, seemed to be concentrated at base of lungs bilaterally.  Slightly worse when taking deep breath. Not really associated with shortness of breath. No other associated symptoms. Made worse by lying down. Slightly alleviated by raising shoulder blades up and sitting with head in hands. Lasted approximately 1.5 hours with periods of worsening and getting slightly better. Was considering going to emergency room given severity of pain, but eventually resolved on its own with no further symptoms since that time. Have never experienced symptoms like that before. Pregnant at time of occurrence, 15 weeks 4 days along.
7"x 7" swelling right outter thigh, St tender5x5 rounded center erythema rrigt out thigh. No limp mp adempaptahy.
2:00 am - headache, abdominal cramping; 7:00 am - cont. headache, diarrhea, fatigue; 7:00 am - 10:00 pm - cont. headache, fatigue; unable to eat or drink; slept most of day; 10:00 pm - cont. headache; lost muscle control and slowly fell (landing on back, but, don't believe  I lost consciousness); diarrhea; 10:00 - went to bed and slept throughout the night until 7am; woke up feeling better; not wanting food or drink
No additional AE reported; During the temperature excursion evaluation it was discovered that V ARlV AX had been administered to a patient on; This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. Pertinent information regarding the patient's concurrent conditions, medical history or concomitant medications was not provided.  On 28-MAY-2021 the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot number T028306 and expiration date 20-AUG-2022) (dose number, route of administration, anatomical location, vaccination scheme was not reported) as prophylaxis. The involved vaccine underwent a temperature excursion of -12.3 degrees Celsius (°C) for 56 minutes. There was no previous temperature excursion reported.  This information was due to a data logger. No additional adverse events were reported. The outcome of the events was unknown.
10/15/2021- I started feeling dizzy and my right leg started getting weak and through the night it my right arm starting getting numb 10/16/2021- Late that night i went to the emergency room and test was done and it was determined that it was a Stroke and i was admitted into the hospital. Hospitalized until 10/18/2021 about 08:00PM ET
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L017143, expiration date 13-MAY-2017; lot # L024250, expiration date 30-JUN-2017; lot # L048465, expiration date 02-DECY-2017; lot # L050560, expiration date 14-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -9.9 degrees Celsius for 14 hours. There were previous excursions of -11 degrees Celsius for 4 hours, -13.1 degrees Celsius for 5 days, -13.6 degrees Celsius for 14 days, -12 degrees Celsius for 2 days, -13.9 degrees Celsius for 3 days, -13.1 degrees Celsius for 5 days, -13 degrees Celsius for 7 days, -11.1 degrees Celsius for 2 days, -12.2 degrees Celsius for 9 days, -14 degrees Celsius for 9 days, -11.1 degrees Celsius for 1 day, -12.8 degrees Celsius for 10 days, -14.6 degrees Celsius for 1 day, -14.2 degrees Celsius for 4 days, -14.6 degrees Celsius for 1 day, -14.8 degrees Celsius for 3 days, -14 degree Celsius for 10 days, -13.7 degrees Celsius for 1 day. This is one of several reports received from the same reporter. Additional information has been requested.
PT RECEIVED FIRST DOSE AT MARCH AND STILL HAVE INJECTION SITE SWELLING.
She received Pfizer Covid 19 vaccination. It should have been Moderna. She received her 1st Moderna shot on 9-18-21
double vision lasting 15 mins-started 30 mins p/inject; sore throat, h/a, muscle aches lasting 48 hrs p/inject;
Area in breast became sore and could feel a dense area. Visited doc received referral to imaging.
Fever Narrative:  Received a telephone call from patient's daughter reporting the following side effects after receiving the COVID vaccine yesterday 1/19/2021: Muscle aches, tiredness, chills, fever (99.9), feeling overall sick. Patient's daughter had already given patient Tylenol for the fever. She was also reporting that patient felt short of breath with O2 sat 85%. As per daughter, he refuses to go to the ED for further evaluation. Provider called this writer later and recommended for patient to take and extra dose of furosemide 40mg in the afternoon and take Advil 600mg twice today with food. Continue to monitor. Patient's daughter provided update on patient's condition. As per daughter, patient is doing better. His shortness of breath is improved. Daughter reports the nurse came out and auscultated his lungs which she said were clear. O2 sat ranging from 88-92%. Patient declined to be enrolled with hospice at this time due to him feeling better. Daughter reported she had given him the Advil 600mg already and patient is afebrile at this time and feeling better. Patient was closely monitored and has been stable. Second dose of vaccine has not been administered.
06/13/2022 Vaccination  07/15/2022 I felt fatigue throughout the day.  07/16/2022 I felt normal all day and felt ok. I came home at 3PM in the afternoon. Within 4 hours I had nasal congestion, sore throat, body aches and muscles. COVID-19 POSITIVE.  Had a hard time connecting with Dr. and prescription. Contacted the local health department. I was able to get a prescription for Plaxovid. 07/19/2022 Starting Plaxovid.
vials were stored in the refrigerator and thawed on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 26-Apr-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 240.  Concomitant medications were not reported.  On 26-Apr-2022, the patient received a first booster dose (Lot: 066H21A) of Moderna vaccine.  Reported that doses were administered after the expiration date/Administered after 30-day use by date. It was reported that patient didn't experienced any known reactions. The vials were thawed the same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Hot after 3rd shot; A little sore throat after 3rd shot; Chills after 3rd shot; Sore right arm after 3rd shot; Fever 101.5 F  after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot). At the time of the report, FEELING HOT (Hot after 3rd shot), OROPHARYNGEAL PAIN (A little sore throat after 3rd shot), CHILLS (Chills after 3rd shot), VACCINATION SITE PAIN (Sore right arm after 3rd shot) and PYREXIA (Fever 101.5 F  after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, Body temperature: 101.5f (High) Fever 101.5F (Normal 97.5F).         No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: This case concerns a 70 years old male patient, with no reported relevant medical history, who experienced the non-serious unexpected events of Feeling hot, Oropharyngeal pain and the non-serious expected events of vaccination site pain, Chills and Pyrexia. The events occurred 1 day after the third dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
-June 2021 Covid vaccine #2, c/o chest pain and tightness for 2-3d. -January 8, 2022 Booster given - c/o chest pain and tightness for 2-3d similar to June 2021 event.
Flu shot given around 6 pm, patient sat & adjusting sweat shirt, for about 10 minutes, returned to the front of the store & passed out behind the front counter; ambulance called; pt left responding.
A few minutes after receiving H1N1 devel red, raised pruritic rash on face, then spread over entire body.
I had a seizure at around 4:00 AM in the morning. I woke up having some heart palpitations and feeling very nauseous. I got up out of bed to get some water, and then I immediately collapsed. My dad in the other room heard me fall and later told me that I was twitching and clenching my jaw for about a minute before I regained consciousness. It never happened to me before, so I'm certain that it was because of the vaccine.
Presented with cervical lymphadenopathy 2 weeks after shot #1; advised to proceed with second dose one day after presenting.  Cervical lymph nodes became more prominent after second dose.  Sent for labs and found to have Acute T-cell lymphoblastic leukemia on flow cytometry.  Was admitted shortly thereafter within a few days for induction chemotherapy
Information has been received from a physician concerning a 7 year old male with hypersensitivity and asthma and a history of eczema who on 11-OCT-2002 was vaccinated with the first dose of VARIVAX (Merck) (lot #643092/0551M) by SQ. Concomitant therapy included inhaled corticosteroid (unspecified), unspecified bronchodilator and cough, cold, and flu therapies (unspecified). Subsequently full panel including VZV titer confirmed that the patient did not seroconvert. On 24-Mar-2004, the patient received the second dose of VARIVAX (Merck) (lot #647709/1247N) by SQ. The patient sought medical attention for his experience. Additional information has been requested.
pt described having difficulty swallowing, denied any allergies but did state she has been hospitalized twice in the past for unknown swelling. denied difficulty in breathing, vital signs stable. Reported feeling fine, pt stated "it was just my nerves." Pt d/c w/ no further complaints. Advised to call for medical care if s/s reoccur or worsen.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant therapies. On 06-AUG-2015, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) lot # K025765, expiration date 08-JUN-2016 (dose, frequency, route of administration not specified) and a dose of VARIVAX (Merck) (dose, frequency, route of administration, lot # and expiration date not specified) during the same office visit. There was no adverse effect reported. Additional information has been requested.
This is a spontaneous report from a contactable Pharmacist. The Pharmacist reported similar events on 2 patients. This is case 1 of 2. A patient of unspecified age (after age 65, unit not provided), ethnicity and gender received PREVNAR 13 (Lot # R28321, Expiry Date 01Mar2018, NDC # 0005197102, UPC # 300051971022) intramuscular at 0.5 ml single on an unspecified date for an immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe reactions on their arms which were described like cellulitis type reactions on an unspecified date with outcome of unknown. The reporter was wondering if they should continue to use the rest of the products from that LOT or if it should be quarantined. Sender's Comments: Based on the information currently available, a contributory role of the suspect vaccine may not be fully excluded towards the occurrence of "severe reactions on arms described like cellulitis type reactions". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-2017087964 Same reporter/drug/AE, different patient.
This literature marketed report as received from a pharmacist refers to a 76 year old patient of unknown gender. The patient's drug allergies and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX while on therapy with paclitaxel and trastuzumab. On an unknown date the patient experienced unspecified rash following the administration which was treated with famcyclovir. The outcome of unspecified rash was unknown. The causality of the unspecified rash was unknown. No product complaint was reported for ZOSTAVAX. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold sore throat), OROPHARYNGEAL PAIN (head cold sore throat), RASH (rash on entire right arm) and VACCINATION SITE PRURITUS (site is itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced NASOPHARYNGITIS (head cold sore throat), OROPHARYNGEAL PAIN (head cold sore throat), RASH (rash on entire right arm) and VACCINATION SITE PRURITUS (site is itchy). At the time of the report, NASOPHARYNGITIS (head cold sore throat), OROPHARYNGEAL PAIN (head cold sore throat), RASH (rash on entire right arm) and VACCINATION SITE PRURITUS (site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
vaccine brand: Pfizer; Moderna; 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 had no relevant medical history. Concomitant medication(s) included: TYLENOL; IBUPROFEN; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand: Pfizer; Moderna". 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 with Paxlovid.  Additional information: Anti-viral details: Product=COVID 19 Treatment: Paxlovid: Treatment start date=27Nov2022, Treatment stop date=01Dec2022 and Indication: Treatment of COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.