chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen eyes; Swollen mouth; Joint pains; Fatigue; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 29Apr2021 (at an age of 56-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications of patient was not reported. It was unknown if the patient received medications within 2 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient was not tested for COVID-19. On 29Apr2021, 5 hours after vaccine, the patient had swollen eyes and mouth, joint pains, fatigue, nausea, vomiting and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The clinical outcome of the events of swollen eyes, mouth swelling, joint pains, fatigue, nausea, vomiting and diarrhea were 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.
pain at injection site/soreness; redness at injection site; swelling; nasal congestion; cough; tonsil pain/ sore throat; the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered); This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis.   On 30-OCT-2023, the patient received Bexsero (intramuscular, left arm) .5 ml. On 30-OCT-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the male patient  should have been given the MCV4 vaccine (Wrong Vaccine Administered)). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site/soreness), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling), nasal congestion (Verbatim: nasal congestion), cough (Verbatim: cough) and oropharyngeal pain (Verbatim: tonsil pain/ sore throat). The outcome of the injection site pain was not resolved and the outcome of the injection site erythema and injection site swelling were resolving and the outcome of the nasal congestion, cough and oropharyngeal pain were not reported and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, nasal congestion, cough and oropharyngeal pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2023 The physician reports that the patient's mother states the patient experienced soreness, redness, swelling, and pain at injection site. The redness and swelling had improved, but pain was ongoing. The patient also had nasal congestion, cough, and tonsil pain or sore throat after receiving Bexsero. The patient was administered a Bexsero Vaccine instead of MCV4 vaccine, which led to wrong vaccine administered. No further details provided, but physician consents to follow up from safety.
Information has been received from a physician and a school nurse concerning a 9-year-old male who on 23-FEB-1999 was vaccinated with a dose of varicella virus vaccine live. It was also noted that the patient was vaccinated with a dose of MMR on23-MAY-1997 and 27-FEB-2001. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a mild case of break through varicella with less than 50 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. A product quality complaint was not involved.  No additional information is expected.
Patient was given a dose of the  Pfizer does without reconstitution of normal saline 0.9%.  Unfortunately my  pharmacy manager has not been able to make contact with the patient's parent/guardian, but we will follow up as needed.
Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever  of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.
Cheeks flushed immediately - vascular rash (did not see until returned home due to mask) Happened again on 4/13  Also arm (left) that received first dose  3 weeks prior became sore again after 2 1/2 weeks (no rash) neck area lymph node pain on left side following first dose in left arm (first week) concerned about potential vascular implications and autoimmune disease
My left hip was in such great pain, it got worse and worse, and this happened 2-3 weeks after my booster shot (3rd dose) and I just noticed all this excruciating pain, specifically shoulder, even after my 2nd dose so that's why I interpret it as a possible adverse reaction. I did see my doctor (during my shoulder pain - 2nd shot) and he mentioned that people have come to him as well as orthopedic doctors mentioned that it is a common reaction. I had the Cortisone shot for my hip - at first it didn't help but after 1 week the pain subsided.
fever of 101 degrees; Chills; Body aches; Headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 03May2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 12Apr2021 at 16:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 22:00, the patient experienced fever of 101 degrees, chills, body aches, headache, and fatigue. The following morning, the fever went away and continue to have minor chills, body aches, headache, and fatigue. On 03May2021 at 22:00, the patent underwent lab test for body temperature and the result was 101 degrees Fahrenheit. Therapeutic measures were taken as a result of the event body aches which included MOTRIN. The clinical outcome of the events fever was recovered on 04May2021, chills, body aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type added, Concomitant Therapy selected None, fever of 101 degrees updated as event verbatim and Event fatigue added.
Diffuse Rash around back and nipple area.  Diagnosed with Shingles and prescribed Valtrex
Fever (103), body aches, chills (lasting 30 hours); after 30 hours felt tired.
NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED VACCINATION (EXP DATE 9/21/21)
Patient came to pharmacy to show me her red swollen irritated arm. Patient was made aware of adverse reaction with vaccination and we decided it was something that needed to be reported with VAERS. Redness swelling irriation itching pain. Did not take any medications. Patient symptoms are now improving.
10:30 Sunday got shot. Almost 12 hrs later she got chills severe. She took Motrin every 4 hours. She had fever at night. It came back Monday. Every time she stopped taking Motrin the fever returned. It felt hot and sore and today is red and blotchy. The size of her palm.
Premature heart beat, up to 6000 occurrences per day. Mostly at night.
Hospitalized 10 days October 21,2021 Cough, headache, weakness, diarrhea, fever breathing difficulties
red in colour; knot that keeps getting bigger; hot to the touch; redness and swelling started at the injection site and grew from there; redness and swelling started at the injection site and grew from there; swelling of the left upper arm; fever; chills; flu-like symptoms; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (body aches) and ERYTHEMA (red in colour) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches). On 11-Aug-2021, the patient experienced ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Aug-2021, PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches) had resolved. At the time of the report, ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm) outcome was unknown.        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.   It was reported that  the patient was not on any concomitant medication. It was reported that the next day 11 Aug 2021after the vaccine was administered  the patient had swelling of the left upper arm, a knot that keeps getting bigger, it is hot to the touch, red in color, and measures 3x3. The patient described the redness and swelling started at the injection site and grew from there.
pt recv vax & approx 5 days post vax pt exp cerebellar ataxia & was hosp;@ the time of the report cerebral spinal fluid had been collected for PCR analysis;
Pt received TDAP in (R) deltoid. Nurse printed copy of vaccine record. Nurse stepped out of room to obtain when returned pt standing in front of desk with mom-fell forward onto desk. Pt laid on floor with feet elevated.
Information has been received from a licensed practical nurse (L.P.N) for the Pregnancy Registry for GARDASIL concerning an 18 year old female with no known allergies and no reported medical history who received two doses of 0.5ml GARDASIL (unknown lot numbers) intramuscularly at another facility, possible in September and November of 2007. The patient is currently taking prenatal vitamins (unspecified brand) and iron supplements (unspecified brand). At 30 weeks pregnancy was discovered during an ultrasound on 23-JAN-2008. The patients LMP is approximately 25-JUN-2007. The ultrasound was performed since the patient said that she had a tumor which was kicking and biting her. No  symptoms have been reported. Estimated date of delivery is 03-APR-2008. Follow up information was received on 17-OCT-2008 from the L.P.N indicating that the patient is a female with no previous pregnancies. On 25-NOV-2007 and 26-DEC-2007 the patient was vaccinated with her first and second 0.5 ml doses, respectively, of GARDASIL (lot # of the two doses was probably 657006/0188U). An ultrasound performed on 23-JAN-2008 confirmed her pregnancy and the results were within normal limits. It was reported that the patient confirmed her pregnancy and the results were within normal limits. It was reported that the patient was late for prenatal care (30 weeks) because she wasn't aware of her pregnancy. Other medication used during pregnancy included prenatal vitamins, once daily from January 2008 to April 2008 and iron supplement, 325 mg daily from February 2008 to April 2008. During pregnancy, the patient developed chlyamdial infection and on 01-FEB-2008, was treated with ZITHROMAX, 1 gram once. The outcome of the chlamdial infection was not reported. On 10-APR-2008 the patient delivered a normal female baby, weighing 7 pounds, 2 ounces. The baby's length was 20, headache circumference was 13.5 and apgar score was 8/9. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during pregnancy or labor/delivery. No diagnostic test was performed during pregnancy. Additional information is not expected.
Anaphylactic reaction. Allergic reaction caused by drug. Conjunctivitis. Blurred vision.
Pt reports that she had a high fever (patient did not have a thermometer), chills, diminished appetite, sensitive skin, and fatigue. She took NYQUIL and slept 15 hours. When she woke up she felt weak. She ate something (her appetite was small )and took TYLENOL then she rested the rest of the day. Her chills were gone at that time but she continued to feel exhausted. She took NYQUIL again that night and slept another 9 hours. She continues to feel weak and have a headache.
He got dizzy, stiff, rolled his eyes, got pale and fell on exam table. He was scared, hyperventilation and holding his mom. After maybe about 30 min. of resting got better and left.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 (Lot number: EW0167) at the age of 42 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "known allergies: Percocet". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0167, Location of injection: Left Arm), when the patient was 42 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Pain in arm"; CHILLS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "chills for two days"; ALOPECIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "now hair loss". Additional information: It was reported as Pain in arm later that night chills for two days now hair loss. No other vaccine was received in four weeks. The patient not received Covid vaccination prior and post vaccination. No follow-up attempts are possible. No further information is expected.
Patient called on the morning of May 1st, 2017 complaining of "red, raised and swollen about 2 inches below the injection site, and inside the bicep". The vaccine was given on April 22, 2017. Patient was advised to use cold compress and take ibuprofen and we will follow up with patient.
SPOKE WITH EMPLOYEE 6/13/07 WHO STATES THAT ONE WEEK AFTER RECEIVING MMR BOOSTER ON 10/25/06 DEVELOPED ONSET OF HIVES THAT HAVE BEEN RE-OCCURING SINCE THEN AND NOW HAS ALSO DEVELOPED TIGHNESS IN THROAT WITH HIVES. HAS SEEN HER PRIMARY PHYSICIAN, A DERMATOLOGIST AND AN ALLERGIST WITHOUT DIAGNOSIS OR RESOLUTION OF PROBLEM. SHE FEELS IT IS RELATED TO THE MMR VACCINE. hAS BEEN TREATED UNSUCCESSFULLY WITH ANTIHISTAMINES (ZYRTEC & ALLEGRA) AND PREDNISONE.
VERY SWOLLEN LEFT UPPER LEG THAT WAS RED AND WARM TO THE TOUCH. PREVNAR VACCINE GIVEN IN UPPER LEG AND ACT HIB GIVEN IN LOWER LEG. LOWER NEEDLE POKE WAS NOT SWOLLEN OR RED. PATIENT WAS ALSO VERY AGITATED MOM STATES HE CRIED FOR PAST 2 HOURS.
Patient receive FLUZONE HIGH DOSE and a day later experience changes in heart rhythm. After checking with doctor found changes in EKG and may think it could be flu shot. Patient is not treated with anything and she doesn't experience anything anymore. Will follow-up.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had five temperature excursions of 0 Celsius Degrees for 24 hours, 0 Celsius Degrees for 24 hours,  1.11 Celsius Degrees for 100 hours, -1 Celsius Degrees for 96 hours, and 1 Celsius Degrees for 192 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator(R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
well demarcated hive approx 1cm by 1cm below site of inj lt arm 2-3min p/vax;given DPH & observed;
Student called SHS on Wed. 4/16/08 stating she had fever to 101.7 night before and her face was red for about 3 hrs around cheeks and sinuses. Appt. scheduled for 1:00 on 4/16/08. At visit no sign of facial redness.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: States bleeding after the injection. States bruised, red, itching and pained. States was at work during first conversation, so chose mild as daily tasks not limited.
This case was reported by a healthcare professional and described the occurrence of worsening of hepatitis C virus in a male subject of unspecified age who was vaccinated with Havrix, for prophylaxis. The subject's medical history included hepatitis C infection. The  healthcare professional reported on 06 September 2006 that the subject's hepatitis C viral load had been "stable for the last year." On an unspecified date in 2006, before 06 September 2006, the subject received a dose of Havrix (1440 elisa unit; dose number and lot number not provided). Approximately 3 weeks later after vaccination with Havrix, on an unspecified date in 2006, on or before 06 September 2006, the subject's hepatitis C viral load "doubled." At the time if initial reporting, 06 September 2006, the outcome of the event was not reported.
Menstrual Cycle Disruptions; 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 MENSTRUAL DISORDER (Menstrual Cycle Disruptions) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual Cycle Disruptions). At the time of the report, MENSTRUAL DISORDER (Menstrual Cycle Disruptions) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to INC.-MOD-2021-090629 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-090621:Cross linked INC.-MOD-2021-090629:Cross linked
Headache; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 08Jan2021 (lot number: EK9231) and first dose on 19Dec2020 (lot number: EN9899); both via unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced headache on 08Jan2021. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included COVID-19 test: negative on 17Dec2020. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Patient received on 14 Jul 2022 a dose of Engerix-B that had expired on 1 Jun 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old patient who received HBV (Engerix B) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 14th July 2022, the patient received Engerix B. On 14th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: The patient received the dose of Engerix-B on 14 July 2022 that had been expired on 01 June 2022. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used. This case was linked with case US2022107249, reported by the same reporter.; Sender's Comments:  US-GSK-US2022107249:Same reporter, same case
A report was received from a health care professional concerning a 22 year old female vaccinee who inadvertently administered last years Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee inadvertently administered last year's Fluvirin vaccine. No adverse event was reported to be associated with the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200651; PJP200200653.
I started to feel congested and had coughing occasionally. I was more tired than normal. Thursday morning I tested and it was negative. I went to work Friday and then came home and retested and was positive for COVID-19. I went to an urgent care and was retested. It was also positive. The doctor suggested that I do the monoclonal antibodies because I cannot do the PAXLOVID. I did the antibodies and discharged me. They advised me that I can take the AFRIN nasal spray. When my symptoms started I was taking CLARITIN D but was advised to not take it. I started to take MUCINEX for my chest and was given steroids. I am still really congested and cough occasionally.
Patient reports warn at injection site, burning down entire arm, very sore arm for 4 to 5 days. Swelling also occured for 5 days.
Vaccination site is red and warm to touch. Area is hard and swollen. Itchy. Approximately 2 1/2? in diameter.