chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received as apart of Varivax pregnancy registry from a physician via medical records concerning a 23 year old female who on 04-NOV-2011 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy incuded a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's priior vaccination inclujded: four doses of diphtheria toxoid  (+) pertussis acellular Biken vaccine (+) tetanus toixoid (on 13-MAR-1989, 01-AUG-1989, 16-OCT-1989 and 06-MAY-1991), one dose of Hib conj vaccine (unspecified carrier) (on 06-MAY-1991), three doses of polio virus vaccine and diphtheria toxoid (+) pertussis acellulr vaccine (unspecified) (+) tetanus toxoid (on 13-MAR-1989, 01-ASUG-1989 and 06-MAY-1991). On 04-NOV-2011 the patient was given the VARIVAX (Merck). At the time of vaccination the patient was 5 months gestation, she did not information nurse that she was pregnancy at the time. At the time of reporting the patient's otucome was unknown. Health care professional contacted during the followup-up could not supply the information about the patient's pregnancy otucome and had no knowledge where she might have had her baby. Additional information is not expected.
This spontaneous report was received from a patient wife concerning to a 55 years old male patient. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) on 15-DEC-2011. . The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) in March 2012. The third dose of GARDASIL had not been administered. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. Additional information has been requested.
Child woke up screaming in pain.  Rocked baby back to sleep.  Woke up twice more that night screaming.
Cellulitis to injection area treatment- KEFLEX 500mg TID x 14 days.
Patient experienced redness, swelling, and fever around the injection site. Pt was given AUGMENTIN 875-125 mg.
red rash on right leg behind knee; burning; rash all over her right leg; hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Stomach discomfort.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot). At the time of the report, RASH (red rash on right leg behind knee), BURNING SENSATION (burning), RASH (rash all over her right leg) and HOT FLUSH (hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Day after vaccine, began to experience metallic and bitter taste.  By the next day (2 days after vaccination) I lost all sense of taste.  My sense of smell is only slightly off.  Even a glass of water tastes horrible.  Acidic foods are worst.  But everything tastes slightly soapy, bitter and metallic to the point where I am having difficulty eating anything (now on day 6 after vaccination).
Muscle Spasms, Joint Pain, Arm Pain, Weakness Overall, Dizziness, Nausea Seen in ER on 08/11/2017 given PEPCID AC as an antihistamine. Seen at clinic 08/14/2017 told to take BENADRYL as an antihistamine. As of 08/15/2017 symptoms have not subsided and the overall weakness seems to be increasing.
PATIENT COMPLAIN OF FATIGUE, LOSS OF APPETITE, HEADACHE. REDNESS AT INJECTION SITE AND TENDER TO TOUCH. HEADACHE WAS RESOLVED WITH TYLENOL 500-MG.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Lot number: Ew0158), in left arm and on 19Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "tree pollen allergy" (unspecified if ongoing), notes: tree pollen allergy; "dogs allergy" (unspecified if ongoing), notes: dogs allergy; "dust mites allergy" (unspecified if ongoing), notes: dust mites allergy. Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Jun2010; ALBUTEROL [SALBUTAMOL], start date: 12Mar2019; SYMBICORT. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine", notes: Known Allergies: Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: prior negative tests; (15Jun2022) Positive, notes: Tested positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: product=COVID 19 Treatment, Paxlovid, treatment start date=07Jun2022, treatment stop date=12Jun2022, indication=Treatment of COVID-19. Patient couldn't sleep first two nights, awful taste in mouth all 5 days, but reported COVID rebound 4 days after last paxlovid pill and after prior negative tests. Tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MODERATE FEVER (101.3F) AND BODY CHILLS- TREATED WITH TYLENOL
Headache, Sedation, Myalgia, Arthralgia, right shoulder joint and muscle pain Narrative:
Around 1:00pm shortly after his shot we noticed he had a red hot patch around where the shot was given, the redness began to get larger, he was laid to nap when he woke up he was head to toe hives. He was taken to the Hospital where they agreed he was having an allergic reaction to the vaccine, he was given Benadryl, the next morning his hives were worse, he had a fever of 103, he was taken to another hospital where he was re-evaluated and started on Prednisone. The hives lasted 3 days, the fever lasted nearly a week, when we learned that the allergic reaction and medication wiped out his immune system allowing him to contract Scarlet Fever.
Second booster given 10 days after 1st; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter indicated that a family member took the patient to get the first booster dose and did not report it back to the nursing home where the patient was living. The patient was currently not experiencing any side effects.  No treatment information was provided by the reporter.
A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm a rash/ rash, warm/ feeling hot, swollen/ peripheral swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events arm a rash, warm, swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm a rash, worm, swollen was unknown.  Based on comment, Peripheral swelling (code to LLT/PT vaccination site swelling which is listed across labels) and Feeling hot (code to LLT/PT vaccination site warmth which is listed across labels)
pt began with vomiting night of imms, persistent non bilious emesis x 2 days, diarrhea day following imms.  af  lethargic, poor po intake, and decreased urine output,  resulting in hospitalization for hydration
101 degree fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number KD424) for prophylaxis.   On 23-OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: 101 degree fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK receipt date: 24-OCT-2023 The patient had 101 degree fever. The reporter consented to follow up.
This report was received from an agency and was assigned manufacturer report number 7108599 for REBIF. Information has been received from a physician and the patient concerning a 45 year old female with multiple sclerosis, nerve pain, headache, depression, tobacco abuse, spasms and chronic pain and a history of cellulitis who on 01-DEC-2011 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (lot # 671553/1138AA, expired on 06-OCT-2009). Secondary therapy included REBIF (lot # AU001935), 4 mcg three times a week by subcutaneous injection from 24-MAY-2011 to ongoing for multiple sclerosis and FLUVIRIN (lot number 1102601 and expiration June 2012). Concomitant therapy included TOPAMAX, 100mg, twice a day for headache, gabapentin, 300 mg, twice a day for nerve pain, ZOLOFT, 200mg, once a day for depression and ZANAFLEX, 2 mg, once a day for spasms. On 01-DEC-2011 the patient went for a routine physical and received PNEUMOVAX 23 in her right arm. On 02-DEC-2011 the patient went to the emergency room due to an allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX 23 and it was hot, red and inflamed. The patient was admitted to the hospital over night when the pain was going to her shoulder blade and in her chest. During the hospitalization the patient had laboratory tests which were negative for cardiac issues and blood cultures that were negative. The patient also had an ultrasound of the upper right arm that was negative for clots. The patient had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX 23. The patient received no treatment while at the hospital. On 03-DEC-2011 the patient was sent back to the emergency room by her physician because the arm was getting worse. The patient was given intravenous vancomycin in the emergency room for right arm cellulitis. The patient then had an allergic reaction with hives and her whole body was itching. The patient was given BENADRYL and antibiotics to prevent her from getting cellulitis. The top of the head of the patient has become spontaneously very itchy since the allergic reaction. The patient reported that she noticed itching of the tip of the head which began in August 2011. The patient continued administrations of REBIF. The patient was discharged from the hospital on 03-DEC-2011 with FIORICET 50/325 twice a day and VICODIN 10/325 daily as needed for pain. The patient had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. Additional information received from a physician on 27-JAN-2012 included medical confirmation event details, discharge medications FIORICET, VICODIN, additional suspect medication FLUVIRIN and an additional serious event (right arm cellulitis). The physician assessed the relationship between allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX 23 as a suspected causal factor. This was originally reported by a consumer. Additional information has been requested.
Pain/redness L arm itchy 6cm x 8cm raised patch some streaking. Keflex 250mg tid x 7d.
LACK OF SLEEP; TRICEP PAIN; ELBOW STIFFNESS; ELBOW TENDERNESS/JOINT PAIN/ELBOW PAIN/SHOULDER PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced elbow stiffness. On 11-APR-2021, the subject experienced elbow tenderness/joint pain/elbow pain/shoulder pain. On JUL-2021, the subject experienced lack of sleep. On JUL-2021, the subject experienced tricep pain. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elbow stiffness, and elbow tenderness/joint pain/elbow pain/shoulder pain, and the outcome of tricep pain and lack of sleep was not reported. This report was non-serious.
Fever Chills Extreme sweating and heat  Body ache Headaches  Lost of apetite Loss of weight
my voice became hoarse after getting the COVID-19 booster shot months ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "my voice became hoarse after getting the COVID-19 booster shot months ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had syncope and dizziness after 1st pfizer vaccine dose at another facility. Patient has previous history of syncope approximately 2 months ago after blood donation was seen and evaluated by cardiologist. Initially skin on face slightly pale, sweaty arms -improved after lying down on bed. Oriented X3, BP 95/57 O2 sat 99% HR 61, was offered apple juice and peanut butter crackers, left ambulatory with his mom, asymptomatic at time of discharge.
Headache, Myalgia, Fever, Diarrhea,  redness, itching, pain, discomfort at injection site, fatigue  Narrative:
9 month male patient was administrated with Kinrix instead of Pediarix; administrated with Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number hb717, expiry date 1st September 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The nurse manager reported that 9 months old patient was administrated with Kinrix instead of Pediarix which led to inappropriate age at vaccine administration and wrong vaccine administered.  No adverse event was reported. The reporter consented to follow up.
A 29 year old female received Flu Shield (2000-2001) vaccine on 11/30/00 and several minutes later, developed chest tightness and difficulty breathing. She then developed a rash on her face, arms and chest and her throat "started swelling shut". The pt began to hallucinate. Her blood pressure was elevated, her pulse rate was 116 and pulse oximetry was 'normal'. She was treated with epinephrine; however, her symptoms persisted. The pt was administered intravenous methylprednisolone sodium succinate and diphenhydramine. She recovered and went home. Within 3 hours, the pt called the physician's office and reported that she was experiencing chest tightness and shortness of breath. She returned to the office and her blood pressure was elevated. Pulse oximetry was still 'normal'. The pt then developed nausea and began vomiting. She was treated with IV methylprednisolone sodium succinate and an albuterol nebulizer treatment. That evening, she was admitted to the ICU and experienced 2 more episodes of chest tightness and "not being able to breathe". Follow up information received 1/29/01 indicated that this patient recovered.
Tongue swelling per patient.  No  obvious  swelling  and visualization or wheezing, hives, itching, redness, dyspnea.  Advised to be monitored until 9:15am, but patient refused to stay the  entire time and left at 8:55 am.
5 hours after receiving vaccine throat felt full sl. diff. to swallow-took BENADRYL. Symptoms did not worsen. 2 days later has red warm area at injection site, throat unchanged. No other symptoms.
The Baby began crying after vaccines given, mother picked baby up and the baby suddenly stopped crying and went limp for approx. 3-5 seconds then immediately perked up and started crying again. The baby was not holding her breath at the time.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 14 months old female patient who experienced fever for 3 days, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route. On an unknown date, the patient developed a non-serious fever for 3 days (pyrexia) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. (Other relevant tests included No lab data.) Final diagnosis was fever for 3 days. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever for 3 days. List of documents held by sender: none
Red streaks from injection site. Lymph nodes swollen and painful. Treated with IV antibiotics, oral antibiotics, prednisone, and ibuprofen.
The day after his shots he had a fever and was very fussy.   He had bouts of vomiting for over two weeks and was so dizzy that he couldn't walk straight.  He cryed an excessive amount for over two weeks.   He had no appetite during this time.  He had fevers off and on as well.  His arm was swollen where he was given two of the shots for over two weeks (and continues to be).  He could possibly have mild encephalitis.
Patient presented to the office for administration of Moderna Bilvalent Vaccine. However when documenting the administration of the vaccine 3 hours later, it was noted that the incorrect vaccine was pulled and administered. The patient received a monovalent booster dose instead of the bivalent booster dose.  CDC was contacted and after discussing with the CDC, the patient was notified of the error and that they will be eligible for a bivalent booster dose in 2 months.  The patient remained in office for 15 minutes post vaccination and did not experience
Patient states she had hives and itching on the arm that the vaccine was administered into, she noticed it starting the day after the vaccine for about 2 days later. Patient used benadryl to help with symptoms and hives and itching were relieved.  Patient also compained of headache, not normal for her after the vaccine as well.
This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. August 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In August 2021, patient experienced inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August). In August 2021, inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Pt started twitching 1 1/2-2 hrs after vaccine was given.
Consumer missed dose of GARDASIL 9; No additional AE; have restarted the dosing schedule on 26-MAR-2021; This spontaneous report was received from the patient's mother, who was referring to her daughter (the patient's age was unknown). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-NOV-2019, the patient received her first shot of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. Due to coronavirus disease (COVID) restrictions, she did not get the remaining dose regime (reported also as missed dose) and have restarted the dosing schedule on 26-MAR-2021 (described as today). No adverse event was reported.
Raised, hot, red, itchy rash started on evening of 6th post shot. Rash spread to approx 6 inches across.  No treatment.