chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Directly following injection patient stated she experienced pain at site followed by flushing of skin, heart racing.  She stated her ear felt full and hot and experienced generalized itching  of neck and arms.  She stated had similar reaction after shot #1 although this was not as severe.  She has history of this type reaction  when in vicinity of  certain foods including peppers and kiwis.  She had taken 75 mg's PO Benedryl (outdated 2019) prior to leaving home.  1:35 PM assessed  patient scratching skin but no redness nor hives present.   BP 130/80, HR 79. No respiratory, GI or CNS symptoms identified. Administered 50 mg's PO Benedryl.  Received same tx. following shot #1. She and husband requested to leave after 30 min observation and no worsening of symptoms.  She would continue Benedry PRN. Pt carries epi-pen and inhaler with her due to history.
Shingrix vaccination, right arm.  Several large rash areas on right upper arm. Itchy, Benadryl helping
Employee denies fever, denies N/V/D. Reports sore throat, body aches, mouth hurts-more like dryness, head congestion and headache.
Within 2 hours of the vaccine being administered, patient developed swelling of right eyelid. Swelling persisted x 24 hours.
Day after- slight temp (99), body aches, stomach cramps and fatigue 8 days after- large rash on arm (slightly larger than a deck of cards), slight temp (99),  stomach cramps and headache
Chills, fever of 103.8, headache, sore arms and legs, nausea, dizzy and weak
This spontaneous report as received from a nurse refers to a 17 year old patient. On 16-JUL-2018, the patient received a dose of PNEUMOVAX 23 lot # N019837, expiration date 21-FEB-2018 because it was accidentally used as the diluent for MENVEO lot number A17057, expiration date March 2019. No adverse effects were reported.
Kidney stone that was already present for 2 years moved and passed.  Started moving 48 hours after the vaccination.
pt recv vax 20OCT98 & devel an inj site rxn characterized by redness & pain;
My hip joints are so bad since I got the shot I can barely walk; its's so painful in my joint; Pain all the time; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received an unspecified dose of BNT162B2 via an unspecified route of administration on 17Mar2021 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On unspecified date, the patient not been able to walk without much pain since got Pfizer COVID vaccine and have been telling to the doctor and they have been telling to patient, they don't wanna report it and the patient's joints are so bad since got the shot, the patient can barely walk and in so much pain all the time. The patient was not success with go away and it's been since march it has not gone away. The patient stated that will sue and want to talk to the person in charge not the Pharmacist. The patient further stated, "I want to report the side effects, I'm not the only one that is having joint problem, I live in an older community and other people are having the same side effects (further clarification unknown), mine are so painful I can even hardly walk its's so painful in my joint. Everyday it's horrible and I thought it will go away. My last COVID shot was 17March and this is 02June now and my problem has not gone away is getting worse and I need help. I would like you guys to pay for it, you gave it to me." The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a nurse practitioner concerning a 23 year old female who on 21-APR-2008 was vaccinated with her first dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included ORTHO-CYCLEN.  On 21-APR-2008 the patient experienced generalized muscle aches and dizziness.  The patient sought unspecified medical attention by contacting the nurse practitioner.  No further information was provided.  Additional information has been requested.
Patient reporst several 20-30 second episodes of dizziness.  10-11 on the day of the vaccine, 5-6 the next day and 1 so far today.  No falls but has stumbled.
Headaches, muscle aches, chills, fatigue, fever, nausea, vomiting. Felt chills and fatigue first, followed by headaches and muscle aches. Fever was treated with Tylenol, vomited twice
24 hours after vaccine fever and 48 hours after vaccine total body hives he has a hx of small hives but not this severe went to ER, received epi pen denies resp/GI symtoms
Other than the already reported headaches I also started developing thrush. I?m obviously not sure that the thrush breakout is related to the vaccine but from my understand I am supposed to report it regardless.
post vaccination; documented seizure,  vitals at 2:56pm BP 110/70 Pulse 78 RESP 99 , hit head,  and was sent to ER by ambulance
Administered Moderna Bivalent Dark pink cap (yellow label) after being notified that monovalent covid vaccines were no longer authorized. Was administered prior to recommendation of using dark blue Moderna bivalent cap (gray label). Recieved Moderna Bivlanet dark pink cap as 2nd dose instead of moderna bivalent dark clue cap
Developed flare-up of gout following 1st dose of Recombivax; 16FEB90 vaccinated w/2nd dose experienced again flare up of gout;
SICK; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 09-JUL-2021 was received on 12-JUL-2021 and concerned 8 patients. 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 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Upset stomach; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032620A and 011J204) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2000.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature increased: 100.1 (High) OTHER. On 26-Jan-2021, Body temperature increased: 100.7 (High) OTHER.         Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Second dose details, contact details and events were added
Headache & Myalgia Narrative: dose 1: day 2 sore arm dose 2: day 2 sore arm; day 1-chills;fatigue;ha' day 2 fatigue bodyache
5x6 cm area redness and swelling, mildly warm. No tenderness, indurated, no fluctuance. C/O some chills. No fever.
Five hours after (7:00 p.m.) patient received the vaccines she began acting as if she were drunk.  She kept on giggling for no reason and acting silly.  This continued until she went to sleep at 11:30 p.m.  She woke up at 5:00 a.m. and was back to her normal self.
He lays on the couch because of the long Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (He lays on the couch because of the long Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included COVID-19 (Was hospitalized for Covid in 2020, before the Covid vaccines were given to the public).   On 16-Sep-2022, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (He lays on the couch because of the long Covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (He lays on the couch because of the long Covid) had not resolved.            No concomitant medications were provided.  After the patient's last COVID booster; it helped him with some of his fatigue and he was feeling better. Because of this he was given another prescription by his doctor for another Covid booster. No one was allowing the patient to take another Covid booster, he does have a prescription like the pharmacy suggested. But he could not get another dose from any pharmacy as it was against CDC guidelines. Because of long Covid, he does not have a life. It affected his eating, how he feels and sleep.   No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710752:Wife case
Headache, lower back pain, nausea, vomiting, loss of unborn child. Lasted for two weeks; resulted in hospitalization. Nurse follow up on 05/18/04: spontaneous rupture of membranes.
104F temperature; shaking; chills; couldn't move her arms; vomiting; diarrhea; losing her taste; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (104F temperature), TREMOR (shaking), CHILLS (chills), MOVEMENT DISORDER (couldn't move her arms) and VOMITING (vomiting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. A16B214 and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (104F temperature), TREMOR (shaking), CHILLS (chills), MOVEMENT DISORDER (couldn't move her arms), VOMITING (vomiting), DIARRHOEA (diarrhea) and AGEUSIA (losing her taste). At the time of the report, PYREXIA (104F temperature), TREMOR (shaking), CHILLS (chills), MOVEMENT DISORDER (couldn't move her arms), VOMITING (vomiting), DIARRHOEA (diarrhea) and AGEUSIA (losing her taste) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 104 104F.
Pt recvd 3 Engerix-B vax; had elevated alanine aminotransferase;
Pt was given Janssen 45mins after the expiration time.  Pt and clinic lead were notified immediately.  Pt reported no adverse effects after 30mins observation. Pt stable and released from the vaccination site.
In 24 hours the resident became confused, lethargic and in respiratory distress. Saturations could not be kept above 90 on 5 liters. She subsequently ended up in the ICU on a ventilator and was diagnosed with 2 large pulmonary embolisms
CLIENT SUDDENLY BECAME DIZZY AFTER RECEIVUNG DOSE-ALSO COMPLINED OF FEELING HOT. 9:10 B/P 138/99 101-PULSE O2 INITIALLY 86-ENCORAGED TO TAKE DEEP BREATHS AND IMMEDIATELY GAVE HER WATER-HUSBAND AT SIDE- CLENT KNOWN TO HAVE ANXIETY WHEN RECEING SHOTS. 9:15 145/95 95-O2-99 CONTINUE TO FEEL FAINT-9:20-143/92-78 ENCOURAGED TO CONTINUE TO SIT AND RELAX- 9:30 146/92 PULSE 85-CLENT ENCOURAHE TO GO GO HOEM AND REST AND CONTINUE TO INCREAE FLUIDS AND IF SYMPTOM CONTINUE OR WORSEN CALL HER DOCTOR OR EMT--ASSITED BY FIREMAN CAPTAIN
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches.  Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
I received Novavax dose 1 adjuvenated in my left arm on 9/24/22 and awoke the next day with increasing stiffness, pain and inflammation in the muscles of my left shoulder and neck.  I attempted to alleviate the pain with the applicaton of warm compresses, over the counter patches such as Salon Pas, massage, gentle stretches, a different pillow and modifying my sleeping positions.  The stiffness and discomfort in my neck persisted for 14 days and have returned intermittently to this day.
Case completed primary vaccination seried in March 2021, then was hospitalized for Covid in September 2021. Hospitalized at:  Hospital.  * Pneumonia due to COVID-19 virus Assessment & Plan She is vaccinated. Symptom onset 9/16, positive test 9/20. Per daughter - declining rapidly without caregiver support. Hx of fever, weakness, cough and congestion. Was 91% on RA but was started on oxygen - has only required 2L. CXR limited but unchanged, known history of chronic lung disease. Completed 5 days of remdesivir. Decadron 9/20-9/30. Off isolation.    Trop was mildly elevated, but repeat stable. She denies cp. EKG with RBBB, SR - similar to prior. . Suspect this is related to her acute illness, follow for now. Last ECHO was in 2015, known diastolic dysfunction.    Slowly improving in strength. Biggest symptom is anxiety and depression related to social isolation Still on 1LPM o2 via nc by 3/oct without significant respiratory complaint.
Severe abdominal pain, fever, nausea, vomiting, diarrhea, headache, myalgia.  Symptoms have remained severe since onset and now for 48hrs since vaccine.  Tx?Zantac 360mg bid, peptobismol q6hrs, omeprazole 40mg.
Pt states when changing shirt that she notice red, warm to touch, rash from upper arm to elbow (approx 15 cm). Painful to touch and difficulty raising arm. MD notified and prescribed pt. steroids.
Gave pt 2 shots separated into each arm. Mom states started to see swelling after they got home; painful to touch; administered TYLENOL some help with pain, site was still red this morning.
Information has been received from a physician concerning a 1 year old female with no past medical history who on 04/20/2001 was vaccinated SC with a first dose of varicella vaccine. Subsequently, the pt experienced a local reaction described as "pox x2," erythema and induration. The pt was seen in the physician's office and subsequently recovered. No further info is available.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3427), on 10Feb2021 as dose 2, single (Lot number: EM9810) and on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 042121A) and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7162B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RALOXIFENE (Aurobundo). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid, treatment start date: 01Oct2022 to treatment stop date: 06Oct2022.  No follow-up attempts are possible. No further information is expected.
A patient of mine had an asthmatic reaction after receiving his first shot; This is a spontaneous report from a contactable other healthcare professional received from medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced asthmatic reaction after receiving his first shot of vaccination on an unspecified date. Therapeutic measures included Benadryl and inhaled steroids by Emergency Medical Services (EMS). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 30 minutes following vaccine I developed Left arm and facial numbness. Slowly resolved on its own over the next 48 hours.
Pt complained of redness and swelling hard knot with pain right deltoid 05/04 yellow fever vaccine deltoid 4.0 x 6.0cm firm. Treated with ice packs, Tylenol. RTC RRN
AFTER RECIEVING FIRST COVID VACCINE PATIENT FAINTED. PT HAS A HISTORY OF FAINTING AFTER VACCIATIONS
Dress syndrome; brain swelling; amnesia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 2, single (Lot number: EL9267) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EL9262), administration date: 31Jan2021, when the patient was 79-year-old, for Covid-19 immunization. The patient did not receive any prior vaccinations within 4 weeks. The following information was reported: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant) with onset 26Jul2021, outcome "unknown", described as "Dress syndrome"; AMNESIA (non-serious) with onset 26Jul2021, outcome "unknown"; BRAIN OEDEMA (medically significant) with onset 26Jul2021, outcome "unknown", described as "brain swelling". The patient underwent the following laboratory tests and procedures: Multiple tests: (26Jul2021) Unknown results, notes: Dress syndrome, brain swelling, amnesia, rehab. Clinical course: Specific relevant test for thromboembolic events thrombocytopenia: None. The patient did not receive Paxlovid.
Patient states she is experiencing arm pain from injection site down the length of her arm and into her back.
Swelling greater than 2mm. Pain, fever. Swelling lasted longer than 5 months and may have been administered further posterior. Still at the deltoid muscle.
Information has been received from physician concerning a 7 year old female with no allergies or medical history who on 15 AUG 2006 was vaccinated in the right upper arm with a first dose of Recombivax HB (lot # 651735/0537R). Concomitant therapy included FLOVENT and Albuterol. On 17-AUG-2006, the patient had a pin point rash on her thigh two days after vaccination. Unspecified medical attention was sought. The patient recovered a couple days later with BENADRYL treatment. Subsequently, the patient recovered from pin point rash. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from a physician who reported that on 17-AUG-2006, in the afternoon, the patient developed a pinpoint rash on her thighs that was raised and pruritic. The rash responsed to BENADRYL which was required for a few days. The patient recovered on approximately 19-AUG-2006 or 20-AUG-2006. There was no reoccurence. It was also noted that the patient had a hepatitis B surface antibody of 24 MIU/ml and a negative hepatitis B core antibody and hepatitis surface antigen. Neither the patient nor her sibling had any adverse events following prior vaccination. No further information is expected.
Started breaking out in a rash on feet and lower legs and developed bruising.  Red spots went to upper thigh and lower back.  A few spots on both arms.
Weakness, continuous high fever for 7 days (103 F), was reduced by Motrin only (ibuprofen), fever reappeared right after medicine stopped acting (after ~8 hours). Accompanied by dry coughing all the time.
Patient only took the 1st shot and was advised by our doctor at the time to not continue, Her issues are as follows: Dysautonomia AMPS POTS Non Epileptic Seizures EDS IBS Mast Cell Activation Syndrome  She was a healthy girl who was accident prone (apparently due to the EDS), but suddenly she was a VERY sick child. It is known in our complex community that alot of cases of kids like mine had the HPV PRIOR to onset of symptoms.
About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. They lasted about 48 hours.  Still have pain in my armpit on left side.
Pt said he had shot a couple months ago but it was in November. He said his arm is still sore from vaccine. The muscle is sore "it hurts deep in arm". Pt is referring to MD.
had the shingles shot and still got them/suspected vaccination failure; still got them; painful; have scars; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and scar. On an unknown date, the outcome of the vaccination failure, shingles, pain and scar were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and scar to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:01-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got shingles.  The reporter stated that it was more painful than having a baby.  The patient had scars from it also. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient experienced redness in her face about 5 minutes after receiving the vaccine.  Was given benadryl and waited around for another 15 minutes to see if any other symptoms occur. Patient had no issue with the redness.