chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had generalized seizure around 11:00 on 7/24/00. No fever or vomiting.
No additional adverse event reported; Inadvertently gave VARIVAX with PROQUAD/the patient was supposed to get only PROQUAD.; This spontaneous report was received from other health professional and referred to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, first dose, (lot number W026319 has been verified to be a valid lot number, expiration date reported as 28-FEB-2024 and validated as 18-FEB-2024) (strength, vaccination scheme, anatomical location and route of administration were not provided); and was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, (lot number X010534 has been verified to be a valid lot number, expiration date reported and validated as 11-APR-2025) (strength, vaccination scheme, anatomical location and route of administration were not provided), administered for prophylaxis. The patient was supposed to get only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (extra dose administered). No additional adverse event was reported.
This spontaneous report was received from the patient's grandmother referring to her grandson a male patient of unknown age. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. In approximately 2010 (reported as "about six years ago"), the patient's mother received a dose of GARDASIL (route, dosage schedule, lot # and expiration date were not reported) for prophylaxis while pregnant. The reporter also stated that since an unknown date (reported as "now") the patient was "acting out" (impulsive behavior). The outcome of the patient's Impulsive behavior and was unknown at the reporting time. The reporter did not assess causality between the event and the use of GARDASIL. This is one of two reports received from the same reporter. The reporter considered the event to be a congenital anomaly. This case has been submitted with an incorrect E2B Linked report reported as 009507513-US-1611USA007732. Therefore, this version is also being created to report the correct E2B Linked report for this case which is US-009507513-1611USA007732. Upon internal clarification, this case has been downgraded from medically significant to non serious. Additional information is not expected as the reported refused contact for follow up. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil and the reported serious event of impulsive behavior cannot be established. In addition, impulsive behavior is not uncommon in the general population. This report also contains the nonserious event of fetal exposure during pregnancy. Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of the product. Sender's Comments: US-009507513-1611USA007732: MERCK 1612USA000539: Mfr number.
Fatigue, pain at injection site and soreness under left arm starting around 11pm on 11Jun2021; fatigue and underarm soreness and still continuing today (14Jun2021); dizziness starting around 6am on 12Jun2021 and still continuing today (14Jun2021); fever and chills starting around 8am on 12Jun2021 and subsiding by around 9am on 13Jun2021; raised, red/irritated skin around injection site, in shape of band-aid that was applied after injection, observed 13Jun2021 and still persisting as of 14Jun2021; increased dizziness and racing heart beat starting morning of 14Jun2021 and still continuing.
at the the inside crease of the elbow a big bulge the size of a small egg on both arms; swelling; a little heat; This spontaneous case was reported by a consumer and describes the occurrence of MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat). At the time of the report, MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: AE contact information updated
24OCT91 normal exam, 1st DTP/OPV/HIB administered; 28OCT91 seen in office for gastroenteritis & acneform rash; 30OCT91 mom called diarrhea, continues, now vomiting also; sent to ER; 31OCT91 pt died;
injection site bruise; arm hurt; redness,persistent redness; raised injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (injection site bruise), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (redness,persistent redness) and INJECTION SITE SWELLING (raised injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE BRUISING (injection site bruise), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (redness,persistent redness) and INJECTION SITE SWELLING (raised injection site). At the time of the report, VACCINATION SITE BRUISING (injection site bruise), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (redness,persistent redness) and INJECTION SITE SWELLING (raised injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SORENESS IN LEFT ARM.  HAS BUMP THE SIZE OF A PEA.  DIFFICULTY PICKING UP CAT.  DIFFICULTY SLEEPING ON LEFT SIDE STILL
Information has been received from a male consumer with a pcn allergy and no other past medical history who on 09/30/2001 and on 01/28/2002 was vaccinated with the first and second dose of hep A vaccine. There was no concomitant medication. Subsequently, the pt stated that results came back saying "not active." The pt sought unspecified medical attention. Follow-up info from a registered nurse reported that the pt's antibody test was "borderline." It was noted that "there was some question about the administration of a second dose." Additional info has been requested.
Right after shot started feeling off, woozy for the entire day. A week later began developing chest pain, went to get tested at urgent care, sent to ER because of fear of pulmonary embolism. At the ER ran some tests on heart (EKG, etc.) Not given any medication. Chest pain lingered for a while, no reaction to second shot. Gut issues persisted throughout
Information has been received from a mother concerning her approximately 2 year old son. In February 2007 and April 2007, the mother with migraine and polycystic ovarian syndrome was vaccinated with the first and second doses of GARDASIL 0.5 mL (lot # not reported), respectively. Concomitant therapy included vitamins (unspecified). Two weeks after receiving dose 2, the mother found that she was two months pregnant. On 13-FEB-2010, the baby was delivered. Subsequently the baby experienced an unexpected fever almost every other day as well as seizures. The baby was also congested all the time and was diagnosed with asthma. At about 6 months old (in approximately August 2007) the baby experienced "a lot of ear infections" and the mother finally switched pediatricians. The pediatricians never referred the baby to an ENT, nor did they suggest tubes in his ears. The baby had tubes placed in his ears about a month or so ago by his new pediatrician, and his speech had really improved a lot- "he was doing much better with that". Now the baby was still having problems with seizures through not as often and his mother thought he was getting much better. The mother felt that seizures, unexplained fever, asthma and "a lot of ear infections" were related to therapy with GARDASIL. Upon internal review, th event of seizures was considered to be an other important medical event. The mother's experiences were captured in WAES# 0904USA01551. Additional information has been requested.
Information has been received from a Registered Nurse concerning an 18 year old male patient who at age 1 year was vaccinated with MMR II (lot # not reported) and 5 years of age he received a booster of MMR II. He will be traveling abroad and recent titers were for measles and rubella but a negative titer of mumps. No symptoms presented. The patient sought attention was at office. Additional information has been requested.
Information has been received from a woman in a physician's office concening a 48 year old female who on approx. 01/26/2001 was vaccinated with hep B vaccine recombinant. On approx. 01/28/2001 the pt developed a rash on her left arm. The rash did not itch and was not raised. Additional info is not expected.
tongue swelled immediately; chin and lip remained swollen; chin and lip remained swollen; This is a spontaneous report received from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included: allergy and blood clots. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient received both shots. After receiving the second shot, the patient's tongue swelled immediately; after a week the tongue swelling went down, but the chin and lip remained swollen. The outcome of tongue swelled immediately was recovering. The outcome of chin and lip remained swollen was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax;choking noises in sleep;mom checked pt & found upper body jerking, Inc salivation & eyes open but unresponsive; pt became cyanotic a/ sz;to er;very sleepy;seen by ped;MD not sure if related to vax;
Fever- in 24 hrs, b/w 99.9 and 102.5. CHills, nausea/1 vomit spell, brief. Cough-productive, aches, fatigue. Most severe symp gone in 36 hrs; approx 24 hrs more to totally done.
I called mom at 4:35 pm on 6/7/16 to follow-up on any adverse reactions. Mom said there are no symptoms out of the norm: "Temperature was under 101F." Symptom appeared a few hours after vaccination of having both MMRV and VARIVAX together and later subsided. Mom had no concerns while on the phone.
Initial report received on 15 April 2009 from a pharmacist. A 42 year old female patient, who has no known allergies, a history of hepatitis B infection, and medical conditions of SJOGREN's syndrome, hypothyroidism, and hyperlipidemia, had received on 08 April 2009 in preparation for future travel a first intramuscular injection of YF-VAX (lot number and site of administration unknown), and an intramuscular injection of a meningococcal vaccine (Trade name, manufacturer name and site of administration unknown). The subject was taking ZOCOR, ZANTAC, Levothyroxine and Belladonna (indication not reported) at the time of the vaccinations. Three days post-vaccination, the patient experienced fever with chills and sweating (lasting four days), generalized malaise, nausea, pain in all joints (without erythema or swelling), congestion with slight dry cough, neck pain, facial pain, headache and transaminitis. The patient was subsequently hospitalized (date not reported) for one day and received treatment with intravenous fluids, MOTRIN, ZOFRAN, and Ketorolac. Diagnostic testing included a CAT scan of the head without contrast, CAT scan of the abdomen, chest x-ray, blood cultures, urine cultures, urinalysis and lumbar puncture. The results of the tests were not reported except for the urine culture and chest x-ray which were normal. Diagnostic laboratory data revealed, ALK Phos 204, AST 122, ALT 201, WBC 4.6, neutrophil 84%, lymph 14%, ANC 3.8, ESR 30, and CRP 52. The patient recovered (date not reported). The diagnosis was viral syndrome versus "YF-VAX." Documents held by sender: None.  6/3/09 MR received for DOS 4/15-16/09 with D/C DX:  Fever NOS and ER record 4/14/09 with dx: fever-sinusitis/viral syndrome. Pt initially presented on 4/14/09 with c/o frontal H/A, neck pain, cough, joint pain and vomiting x 3 days. Recent travel to Africa.  Already on abx from PMD for suspected sinus inf. To ER with worsening sx. Tx with IVF and abx and d/c.  Returned next day with abd pain, photophobia, nausea, rigors, chills and mild facial swelling. Febrile and tachy in ER. PE (+) for abd tendernes of RUQ. Admitted for eval and d/c next day. ICD9:3393-Drug induced H/A.  E9493 YF Vax causing adverse effects in therapeutic use. 07999Y Unspecified viral infection.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: PRAMIPEXOLE (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: I tested positive with symptoms after completing Paxlovid; Negative, notes: I tested positive with symptoms after completing Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist refers to a 26 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-JAN-2017 the patient was vaccinated with GARDASIL (dose, units, frequency, route, lot number, expiration date not reported), on 08-JUL-2017 with GARDASIL 9 and on 24-SEP-2017 with GARDASIL 9 (dose, units, frequency, route, lot number, expiration date not reported). The patient received an off schedule dosing of GARDASIL/GARDASIL 9. On 23-FEB-2018, the patient went to the pharmacy to receive another dose of GARDASIL 9. No adverse effects were reported. No further information was provided. No product quality compliant (PQC) was present.
Vaccine administered 9-27-10 1:21 PM (1321) approx. 15 mins. later had numbness tingling of lips & tongue, which progressed to flushed feeling, nausea & headache. She had flushing upper chest. No itching, swelling or trouble breathing. To E.R. 3:15PM. T 100 F. O2 saturation 99 room air. IV BENADRYL 25 mg, IV SOLU-MEDROL 125mg. Discharged home 5:50PM - Improved.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 168101, expiry date 30th November 2018). Concomitant products included MENACTRA and Tuberculin PPD. On 3rd July 2017, the patient received the 1st dose of BEXSERO (intramuscular). On 3rd July 2017, several minutes after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by a Medical Assistant (MA). The patient received BEXSERO in the left deltoid. On the same day, the patient received MENACTRA in the right deltoid and tuberculin purified protein derivative (PPD) on the left arm concomitantly. It was reported that the patient had swelling and redness at the injection site down to the elbow.
Fever of 103, headache, rash on back, neck, and front torso. Has not been in contact with any outside individuals, no ability to receive chickenpox due to closed contact. Fever persisted for 2 days, the rash has now spread and multiplied onto entire body surface all areas except internally, with blisters. This was on her 2nd round of immunizations for Varicella, no prior adverse reactions.
Severe, debilitating arm/shoulder pain. Slight fever. Shaking for one evening. Pain 10/10 at onset still lasting after 4 days and continues now at about 8/10.
Immediately following injection my heart rate increased to 170 bpm intermittent chest pain has continued since. At times it feel like someone is squeezing my heart. Energy levels have remained low in comparison to before I am ALWAYS tired.
Local reaction to immunization-red raised area increased in size. 20 x 20 cm red well demarcated reaction. Rx with nepo mediol, melone, elevation, rest, ice, Benadryl, Ibuprofen
This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR-QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR-QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.    No treatment information was provided.
Severe night sweats for 20 days Rash on both arms, face, and right arm pit
Flushing in the face, body aches, fatigue, headache, nasal congestion, swelling at injection site, itch at injection site, red circle at  injection (approximately 3" in diameter).  I took Advil ever 8 hours starting  at  4:00 pm on 11/20/20.  I also took one dose of Benedryl at 9 pm on 11/21/20.  I woke up at 3:00  am on 11/22/20 in a pool of sweat.
feels weak; feel like a knife was in his vein cutting him; could not lift his left arm; has Right leg and face tingling; left side of his face was numb sometimes; He guess it was in his lymph nodes; armpit pain; he only received 1 dose of Moderna COVID-19 vaccine and he had side effects so he did not get any more; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (feels weak), FEELING ABNORMAL (feel like a knife was in his vein cutting him), VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift his left arm), PARAESTHESIA (has Right leg and face tingling) and HYPOAESTHESIA (left side of his face was numb sometimes) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004C22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak), FEELING ABNORMAL (feel like a knife was in his vein cutting him), VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift his left arm), PARAESTHESIA (has Right leg and face tingling), HYPOAESTHESIA (left side of his face was numb sometimes), VACCINATION SITE LYMPHADENOPATHY (He guess it was in his lymph nodes), AXILLARY PAIN (armpit pain) and PRODUCT ADMINISTRATION INTERRUPTED (he only received 1 dose of Moderna COVID-19 vaccine and he had side effects so he did not get any more). At the time of the report, ASTHENIA (feels weak), PARAESTHESIA (has Right leg and face tingling) and AXILLARY PAIN (armpit pain) had not resolved and FEELING ABNORMAL (feel like a knife was in his vein cutting him), VACCINATION SITE MOVEMENT IMPAIRMENT (could not lift his left arm), HYPOAESTHESIA (left side of his face was numb sometimes), VACCINATION SITE LYMPHADENOPATHY (He guess it was in his lymph nodes) and PRODUCT ADMINISTRATION INTERRUPTED (he only received 1 dose of Moderna COVID-19 vaccine and he had side effects so he did not get any more) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   He states that he only received 1 dose of Moderna COVID-19 vaccine and he had side effects so he did not get any more. Right away after vaccination he could not lift his left arm (Injected Arm) arm above his head, and he had left arm pit pain. He still has mild armpit pain. He states, it was in his lymph nodes. He states that he still has right leg and face tingling. He states, He feel like a knife was in his vein cutting him. The left side of his face was numb sometimes. His body was not acting as it should. He states the tingling in the face comes and goes. He still feels weak sometimes. The only thing that concerns him was mild tingling in his right leg. He was really calling to get compensated.   No treatment medication was provided.