chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that she received both shots in her right arm and when she woke up the next morning, her right upper arm where she received vaccines from shoulder to elbow was swollen and red.  She also states that her opposite (left) side of her face was hurting and her left ear felt clogged.  This lasted for about 4-5 days then resolved.
Covid Breakthrough - 05/07/2022  I Felt lousy, I felt like I had a cold, since then I feel not as ill, for the first 2 days.  I have never had a fever, I was sneezing and coughing, I had a lot of mucus. for the couple of days. I currently have mostly mucus congestion in my nose and throat. I tested and started Paxlovid on 05/11/2022.  I am just laying around in my room and just laying around.
day p/vax pt thigh became red & enlarged to sz of an eggplant. treated w/cold treatments & benadryl
Arm hurt; Feel yucky; Had the booster about 3 hours ago and have a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache). At the time of the report, PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021 contains significant information: Event added
Information was received on 04-APR-2017 from a nurse who was reporting on a 12 month old male patient. Concomitant medications and medical history were not reported. On 03-APR-2017, the patient received a dose of VARIVAX (lot M010484, expires 01-MAR-2018) intramuscularly and a dose of PROQUAD (lot M043308, expiration 24-APR-2018) intramuscularly at the same time. No symptoms were reported. No other information was provided. Additional information has been requested.
Vaginal Spotting and slight cramps approx 24 hours after initial shot - continued spotting for 3-4 days. Missed/late menstrual cycle (currently 7 days late) No pregnancy
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not provided. No treatment medications were not provided.
This case was reported by a healthcare professional via a GSK sales representative and described the occurrence of gagging on medication in infant subjects of genders who were vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified dates the subjects received a dose of ROTARIX (details unknown) and experienced gagging on medication. The healthcare professional reported that they were having multiple issues reconstituting ROTARIX. It was not mixing up no matter how much shaking the vial and several babies who received the vaccine were gagging after taking ROTARIX. At the time of reporting, no further information was available. At the time of reporting the outcome of the event was unspecified. This case was reported as a product complaint. An investigational report received via GlaxoSmithKline quality assurance on 28 February 2012 indicated that no lot number was available and there was no sample of return. Based on the fact that no precise technical problem considered this complaint as unsubstantiated.
p/vax pt devel bumps on back, stomach w/some itching;dx chickenpox but the lesions were not counted;
WE GAVE TDAP VACCINE(BOOSTRIX) ON 06/21/21 AROUND 2:43 PM AFTER WE FINISH GIVING VACCINE PATIENT LOOKING DOWNWORD AND THEM FROM CHAIR HE SYNCOPE(FAINTING) AND FALL DOWN ON THE FLOOR ON HIS ABDOMEN AND THEN WE GO TO PATIENT AND  ASK ARE YOU OK , ARE YOU OK  , DO YOU NEED ANY HELP , HE RESPOND BACK HE IS OK AND HE JUST PASSED OUT  BUT HE IS COMPLETELY FINE  THEN WE HELP HIM TO  SAT HIM IN A CHAIR , HE SAID HE  IS  HOT AND HAS SWEATING SO WE TOOK FAN OUTSIDE AND MAKE HIM COMFORTABLE AND GAVE WATER TO DRINK , WE GIVE HIM SOME TIME TO SETTLEDOWN AND WE ASK HIM HE HAS ANY HEALTH ISSUE LIKE DIABETIC , HYPERTENSION , HYPOTENSION AND HE SAID HE DONT HAVE ANY HEALTH CONDITION  AND HE IS NOT TAKING ANY MEDICATION HE IS PERFECTLY HEALTHY HE SAID , EVEN THOUGH WE ASK HIS PERMISION TO CHECK BLOOD PRESSURE HE SAID OK  AND BLOOD PRESSURE WAS  NORMAL  SYSTOLIC 127 AND DIASTOLIC 81 , WE KEPT EYE ON HIM AND TOLD HIM TO WAIT ATLEAT 30 MINUTES AND HE SAID THATS FINE SO HE WAITED  AROND 30 MINUTES  AND WE ASKED HIM HE IS FINE AND HE SAID HE IS COMPLETELY FINE HE CALLED HIS WIFE AND HIS WIFE IS COMING AND THEN HE SAID HIS WIFE IS HERE SO WE WALKED WITH HIM TO THE DOOR AND HE SAID HE IS OK NOW AND HE CAN TAKE CARE HIM SELF SO WE SAID GOOD BUY AND TOLD HIM PLEASE CONTACT US IF HE HAS ANY ISSUE AND TOLD HIM WE WILL CALL HIM NEXT MORNING TO MAKE SURE HE IS OK .
Headache, chills, dizziness, body aches, swollen lymph nodes.
About 9 PM headache started and I had that until Saturday morning. I don' t get headaches that often so it was unusual. I took Tylenol - which helped.  I was admitted to the hospital for February 8 for bronchitis. About the fourth of February is when I started getting symptoms of this. I was in the  hospital from the 8-10th. Hospital. Bronchitis resolved around the 20th of February.
:Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number-00732218) and transmitted to Sanofi on 19-Aug-2021.  This case is linked to case 2021SA279787(CLUSTER).  This case involves a five-year-old female patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE , MUMPS VACCINE LIVE , RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 09-Aug-2021, the patient received a second dose (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o PregnancyNA. Last menstrual period. Due date. AE symptoms or no AE."  No adverse events were reported at the time of this report.  The outcome of the event was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, dose not provided), subcutaneously in the abdomen. No adverse effect reported. Additional information has been requested.
The patient has a history of anxiety and passing out with vaccinations. The patient did not tell us she had this type of reaction to vaccinations in the past. The technician, administered the Janssen COVID-19 vaccination to the patient. The patient sat down in the observation area. 5 minutes later, she notified the pharmacy staff that she may have fainted in her seat. She has a couple of abrasions on her face and felt soreness in her nose. She was given water and orange juice and rested in the observation area for another 30 minutes. She said she felt fine and went home.
The filler in my face swelled and was coming through my lips. I have had 64 injections to stop the pain and swelling of hyaluronidase, prednisone. To this day I am still having flare ups & and to keep getting injections to dissolve the filler.
Day 1: Some blurred vision and labored breathing immediately after injection*, numbness and tingling of the tongue, body aches and pains all day. Day 2: Vision and breathing now normal. Numbness and tingling of tongue has lessened. Body aches and pain more prominent. * Please note that this mobile clinic that came to my mom's home was not set up for a serious reaction, nor did they stay and wait at least 15 minutes. My mom was told that she would have flu like symptoms and then they left.
Headache, redness, ? hives. Tx'd with Zyrtec 5 cc PO
Swollen arm, like a big ball; swollen arm, like a big ball; arm was red and hot to the touch; arm was red and hot to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Drug allergy (tetracycline) and Diabetes. Concomitant products included INSULIN for Diabetes.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball) and ERYTHEMA (Arm red). 23-Jan-2021, the patient experienced FEELING HOT (Arm hot). The patient was treated with Physical therapy (Put ice on arm) for Feeling hot. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had resolved and VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) was resolving.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was reported that one hour after the vaccination the patient had a swollen arm, like a big ball, and the arm was red and hot to the touch. Symptoms were still ongoing. The physician advised to put ice on it.  The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains information regarding outcome of the events.
Vomiting and diarrhea for the past 7 days. NBNB emesis (multiples times) and watery diarrhea (>5 times per day). Abdominal distension and a maculopapular rash (non-pruritic or painful) in the back and torso since 2 days ago.
Pt has asthma and was given MedImmune (FLUMIST) H1N1.
Numbness from the left hip to the left leg.; I have a severe pain; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 43 years), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:45 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included astemizole (TYRENOL) within 2 weeks of vaccination. The patient reported severe pain and numbness from the left hip to the left leg on 11Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Ovid has not been tested prior to or post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
"COVID arm" - welt developed at injection site within 24 hours of injection and continues to grow in size and height; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: FO7218) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing), notes: Known allergies: Iodine and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: LEVOTHYROXINE; MONTELUKAST and ALLEGRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8727; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 23Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8731; Anatomical Location: Left arm; Route of administration: Unspecified), administration date: 13Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE URTICARIA (non-serious) with onset 27Dec2021 at 12:30, outcome "not recovered", described as ""COVID arm" - welt developed at injection site within 24 hours of injection and continues to grow in size and height". Therapeutic measures were not taken as a result of vaccination site urticaria.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.
itching at the injection site; This spontaneous report was received from a physician refers to a female patient who is currently 18 years old. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 04-SEP-2018, the patient was vaccinated with first dose, of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. Patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis on 13-NOV-2018. On an unknown date, after the second dose of vaccination, patient experienced itching at the injection site (injection site pruritus). No treatment was given for the event. The outcome of injection site pruritus was unknown. Causality assessment was unknown. Product quality complaints was not involved. The physician reported that, he noticed this adverse event when patient came for office visit at the end of April 2019.
25AUG low fever 101, tired, aching all over, esp hands & feet;26AUG no fever, joint pain cont;saw MD OCT95 mono was r/o, WBC nl;5JAN96 phone call from mom joint pain & fatigue cont;plans to see MD again soon;
Three hours after the vaccination, my heart started beating very rapidly.  I went to the Urgent Center and my heart rate was 161 and my blood pressure 174/113.  When they gave me an EKG, I was in aFib.  I was sent by ambulance to Hospital where another EKG, an xRay and some blood tests were taken.  I was kept overnight and released the next afternoon after my blood pressure and heart rate was lower.
Impaired mobility of arms and legs, impaired function of bladder, weakness in hands, pain.
administration of Shingrix to patient that was stored at 30.308F x 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277T, expiry date 16-AUG-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration of Shingrix to patient that was stored at 30.308F x 20 hours).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 6th September 2023 The pharmacist reported administration of Shingrix to patient that was stored at 30.308F x 20 hours. Unknown date of administration. The permission for safety follow-up was not asked. The shingrix vaccine was stored at 30.308F x 20 hours which led to incorrect storage of drug.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Pt urinated while unconscious-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Pt reported no feeling well. Denied trouble breathing/swallowing. Pt lost consciousness. We were able to prevent him from falling or any\r\ninjury. 911 was called. He was out about 15 seconds. Regained consciousness. Was startled and confused but was quickly became reoriented to where he was, that he had just recieved vaccine and passed out. Patient's BP and condition was monitored until paramedics arrived.  After coming around patient started to feel nauseous and felt like he would vomit.
Pt recvd 2 doses of Engerix-B & recvd 3 of Engerix-B 10JUN92; 3 to 4 days p/dose 3 pt exp flu-like sx, swollen joints, red spots, rash, numbness of fingers, pain in joints, fingers tingling, hands swollen, face puffy;
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/28/2021.
5 year old patient was given pentacel in error (with no reported adverse event); pentacel vaccine code 242 with batch number UJ806AA was administered (with no reported adverse event); Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old female patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] of code 242 with batch number UJ806AA in error (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), both for Prophylactic vaccination.  On 02-May-2023, The Physician misread the birthdate and thought that the patient was 4 and the patient of age 5 received a dose of suspect Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine of standard strength at 0.5 ml dose, suspension for injection of code 242 with lot: UJ806AA via intramuscular route in the right deltoid for prophylactic vaccination (Immunization) with no reported adverse event (product administered to patient of inappropriate age) and (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This non-serious spontaneous case, initially received from pharmacist on 29-Mar-2018, concerning a 35-year-old, adult, female patient. The patient's medical history and medication history was not reported. On 15-Mar-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: 30-Jun-2018). On the same day, about an hour after vaccination, the patient had pins and needles sensation in her left arm. The patient consulted physician but was referred to contact pharmacist. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. Follow-up information received from the pharmacist on 19-Apr-2018: The pharmacist stated that the patient did not receive treatment for event initially and she was not aware of the treatment or resolution of event. She added that, there was no permission to contact the patient and hence this report had been considered lost to follow-up.