chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 7.3 Fahrenheit (F) (6 F to 14 F) for 10 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hepatitis B vaccine for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received injections of hepatitis B vaccine on 9/15/97, 11/17/97, and 4/27/98. he also received diphtheria and tetanus toxoids or diphtheria and tetanus toxoids and pertussis vaccine or diphtheria and tetanus toxoids and acellular pertussis vaccine 9/15/97, 11/17/97, 1/20/98, and 1/25/99; haemophilus influenzae type B conjugate vaccine 9/15/97, 11/17/97, 1/20/98, and 10/26/98; poliomyelitis virus vaccine  9/15/97, 11/17/97, and 1/25/99; MMR 10/26/98; and varicella virus vaccine. The subject's attorney alleged that, as a result of mercury in thimerosal-adulterated infant injections that the subject received as an infant, he now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. The attorney also alleged that the subject will be hindered and prevented from pursuing an normal course of employment.
Patient mentioned he had a small itchy rash along part of his shoulder, along with pain near the injection site.  The pain comes and goes even after 20 days since the vaccination, the rash is still present. Pharmacist encouraged patient to contact primary health care and have them examine him and see if they need to administer corticosteroids for the rash.
patient said that she experienced shivering and she blacked out in her car while driving home and hit a car and ended up in Emergency
I received my first dose on February 10th, 2021, and my second dose on March 4th, 2021. On March 6th my right foot began to feel sore on top of the foot. There was a slightly swollen spot about 2 inches in diameter. It felt sore and swollen for several days, resolving around March 8th or 9th. No other effects.
Rash on arm below injection site, approx 1.5 x 3 in., painful and warm to touch, sometimes itchy. First noticed on morning after injection. Still there (now 3 days after injection). Another rash (no symptoms other than redness) on chest appeared 3 days after injection.
Received the shingles vaccine on Thursday 4/20/2017 about 4:30 pm. On Friday evening 7:30 pm I was itching at the injection site. I looked in the mirror, and there is a 2 inch ling, 1 inch wide red raised rash. There is also a small 1/2 inch circle rash along side the larger rash. They are both itchy hot areas.
Patient reported extreme pain in the arm, low grade fever and malaise. He went to a walk in clinic and was seen 2 days after receiving the shot. He then came to his PCP on 4/26/17 and symptoms were resolving.
whole body is drenched in sweat; buzzy feeling in her head; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling high in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy (intramuscular, right arm). In AUG-2023, 4 days after receiving Arexvy, the patient experienced feeling high (Verbatim: buzzy feeling in her head). On an unknown date, the patient experienced sweating (Verbatim: whole body is drenched in sweat).  The patient was treated with ambiguous medication nos (Claritin (Nos)). The outcome of the feeling high and sweating were not resolved.   It was unknown if the reporter considered the feeling high and sweating to be related to Arexvy.     It was unknown if the company considered the feeling high and sweating to be related to Arexvy.   Additional Information: GSK Receipt date: 08-SEP-2023 The patient reported that she receiving her AREXVY vaccine on 28 August 2023 and after 3 or 4 days later she began experiencing sweats once or twice per day, in which her whole body was drenched in sweat.  She also reports a buzzy feeling on her head that was improved with Claritin but did come back when the Claritin wore off.
mild case of shingles/ suspected vaccination failure; shingles; Got hives; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 PANDEMIC VACCINE) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Shingles vaccine and COVID 19 PANDEMIC VACCINE at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and hives. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and hives were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and hives to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. It was unknown if the reporter considered the vaccination failure, shingles and hives to be related to Covid vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Tightness and pain n the chest, shortness of breath, aching feeling in the upper back, lethargy/loss of energy, heart palpitations. cold feet and hands.
patient fainted about 5 min. after receiving the shot. Hit her head on the floor, was immediately awake, alert. Paramedics checked her out and said she was fine.
i was almost at the end of my period when i received the first shot that night i had severe abdominal cramping followed my profuse bleeding which as of today 4/18/21 is still continuing.  Today 4/18/21 i am severely fatigued.
INFANRIX - DTaP expired 9-6-14 and 1 dose given 9-9-14. No reaction - no treatment.
This spontaneous report as received from a physician refers to a 2 year old female patient with allergy to natural rubber, adhesive allergy and allergy to latex. The patient's medical history included chickenpox (CP), "PR" and seizure. On 25-OCT-2013 the patient was vaccinated with her first dose of VARIVAX (Merck) (lot number, dose, route and site of administration were not reported). Concomitant therapies included REGLAN, MAGNESIA, BACTOFEN, diazepam (manufacturer unknown), topiramate, KEPPRA, phenobarbital and KLONOPIN. On 13-NOV-2013, the patient experienced chickenpox with a couple of vesicles, mostly crusted (about 20) on legs, low abdomen and lower back. The rash "blister" occurred at the site of injection approximately 10 days post-vaccination on left thigh. In November 2013 the patient recovered from adverse events. The patient did not have recent exposure to chickenpox and shingles. The relatedness between vaccination with VARIVAX (Merck) and adverse event was not reported. Additional information has been requested.
Mild to moderate fatigue; Mild muscle aches; Left arm soreness; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 330268D) via an intramuscular route of administration in the left arm on 03Nov2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic autoimmune hives and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included orlistat (ALLI), melatonin (MANUFACTURER UNKNOWN), probiotics (unspecified) and multi vitamin injection (MVI) (unspecified); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 41-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021, approximately at 20:00, the patient experienced left arm soreness and was resolving as of 04Nov2021 at 17:00. On 04Nov2021, approximately at 12:00, the patient experienced mild to moderate fatigue and mild muscle aches and was ongoing as of 04Nov2021 at 17:00. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm soreness was resolving; while that of mild to moderate fatigue and mild muscle aches was not resolved at the time of this report.
On 6/18/18-Patient's Mother was insistent that child needed Tdap and not Dtap. Mother argued with Physician and her child needs Tdap. Physician gave in and told MA to give Tdap. On 8/6/2018 patient's School Nurse called and stated she reported the wrong vaccine was given and she reported clinic. On 8/27/2018 I called CDC to make sure patient/child was not harm by adult dosage. CDC stated reviewed child's immunizations and stated since child had received already 3 dosed of Dtap previously he will be ok and no need to repeat any dosed.
This is a spontaneous report from a contactable consumer via a pharmacist. An infant male patient of an unspecified age and ethnicity received a single dose PREVNAR, via an unspecified route of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a high fever. The patient was brought to the hospital by the patient's father and "tried everything to control the patient's temperature". The patient's temperature decreased to normal. The clinical outcome for the event of a high fever was unknown. Follow-up (23JAN2015): Follow-up attempts completed. No further information expected.
THE PATIENT EXPERIENCED IMMEDIATE PAIN AFTER THE INJECTION HIGH IN THE LEFT DELTOID (IN THE DIVOT AT THE SHOULDER JOINT). PATIENT ALSO EXPERIENCED LIMITED RANGE OF MOTION IN THE SHOULDER. PAIN AND LIMITED RANGE OF MOTION LASTED 5 DAYS, THEN GOT BETTER ON ITS OWN WITHOUT THE NEED FOR MEDICATION.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "ALLERGY" (unspecified if ongoing), notes: known allergies: Yes. There were no concomitant medications reported as, the patient did not receive other medications within two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 18May2022 to 22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reported today to our Health Center with complaints of vomiting and fevers of 103. Today at 103.3R.  Dr requesting reporting for possible adverse reaction to vaccnes.  CBC and UA pending.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N012131 expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with sterile diluents (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Has been over two weeks now and I am having arthritis symptoms in my left elbow elbow, and now in my neck. I?ve never had any of those type of symptoms call mom and I haven?t done anything outside of my normal routine. Elbow has a  constant bad ache.
BLURRY VISION; PAIN IN EYES; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced pain in eyes. On 11-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurry vision, and pain in eyes. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient was in waiting area after the shot, fell from his chair onto the floor unconscious for a moment. scraped his forehead, some blood. offered him water, which he drank all of it, and had staff member watch over him very closely. once he was fully coherent, patient said he has anxiety of shots/needles. He denies any trouble breathing or itchiness/rash. Says he feels some numbness in his hands as well. He denied the offer to call 911 or go to urgent care
I was diagnosed with atrial fibrillation on 10/20/2022 through a routine EKG.  Since then, I have had afib on and off again.  I consulted Dr., who prescribed 2 medications-- Eliquis tablet 5 mp every day and Metoprolol Tartrate tablet 25 mg every day.  I have had EKGs prior to 10/20/2022 but none detected afib.  (I did not have an EKG after first taking the vaccine on 2/9/2021 until 10/20/2022).
Headache; Sweat for about a hour; Really tired; Body aching; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills). On 15-Apr-2021, the patient experienced HEADACHE (Headache). On 15-Apr-2021, HYPERHIDROSIS (Sweat for about a hour), FATIGUE (Really tired), MYALGIA (Body aching), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  No concomitant medication provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-137951 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body rash still in progress
Pt reports facial swelling, redness, and burning sensation. Pt was tx'd by PCP with 7 days of prednisone and once daily 2nd generation antihistamine. Sx's resolved by end of tx course.
Rumbling started in left ear and chirping in right ear. It happens 24 hours a day. Never stops. On May 10 the volume increased. On May 27 volume increased again making it hard to sleep. Diagnosed myself that it's tinnitus.
90 minutes after receiving vaccine, felt like had an apple in her throat. Went to walk in clinic; 10/16/12 at 12:45 pm and given Epinephrine 0.3 mg SQ, SOLUMEDROL 125 mg IM, BENADRYL 50mg IV, Prednisone 60 mg PO, then Prednisone 60 mg orally x 3 days.
Patient developed a noticable stutter in speech following the flu shot that was not present before the shot.  She also seems unable to form sentences properly and frequently uses jumbled words.  She is unable to comprehend shapes, colors, letters or numbers.  Again, this was not the case prior to the flu shot. It should also be noted that patient had eczema as an infant that was related to food intolerances.  This cleared up with a proper diet.  However the eczema returned on the back of her arms and on her torso following the flu vaccine and will not clear up.  It has also been determined that she is intolerant to artificial food coloring which only developed after the flu vaccine.
unconsolable crying x 40 min(s), to primary care provider, instructed not to take pertussis vax, on meds
This case was reported by a physician via other manufacturer and described the occurrence of injection site cellulitis in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to BEXSERO. Additional details were provided as follows: This case was received via Merck National Service Center. Another physician reported to the reporting physician that the patient was diagnosed with cellulitis after receiving an unspecified number of doses of BEXSERO. No additional information was provided. This case has been reported to case US2016GSK015756, reported by the same reporter.
Patient did not have an AE today to our knowledge, however she received the Moderna vaccine on 2/26/21 and was scheduled for her 2nd vaccine today, 3/26/21.  Our clinic was changed to a Pfizer clinic for today.  It appears that the patient was not reachable after multiple attempts to let her know that we needed to schedule her 2nd Moderna to a different day.  Our clerk checked her in today and the RN administered the Pfizer vaccine.  Our clinic administrator is trying to reach the patient to let her know this.  Per our COVID medical director, the patient has now completed the series.
Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in lower part of left arm and right leg, thought it was just muscle pain like the flu. My arm and leg started tingling and going numb, would wake me up at night. Had a Dr. appt. on March 18 when I mentioned I had numbness and tingling, but thought it was just side effect from the injection. Saturday, March 20 called 811 and nurse recommended I get it checked out. Monday, March 22 called my Dr. office, but no openings. Started noticed tingling and numbness is left leg as well. March  23 went to ER regarding my concerns. Dr. checked me and said to keep an eye on my symptoms; GBS was brought up and he said it could show in up to six weeks.
Fever and chills 36-48 hours after the second vaccination.  Sore arm, sore muscles and fatigue  6 days later.
Pt had a vasovagal reaction after receiving the first dose of the Pfizer vaccine. Pt was transported by wheelchair to a cot and assessed by the site paramedic. Pt reports feeling much better after eating crackers.   1448 Vitals: BP 108/64, HR 74, O2sat 99%, RR 18 Sx: pale/moist skin, re-assed 5mins later and found to be warm, dry  PMH: Asthma Medications: Albuterol prn, Xyzal prn Allergies: Penicillin
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 2nd dose of SHINGRIX. On 15th September 2018, 30 days after receiving SHINGRIX, the patient experienced shoulder pain, arthralgia and low back pain. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the shoulder pain, arthralgia and low back pain were unknown. It was unknown if the reporter considered the shoulder pain, arthralgia and low back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. In the middle of September, the patient experience pain in both shoulders, into his left wrist and in lower back. The patient noted the pain does feel like it was in the joints. The patient denied any previous arthritic or joint pain before this incidence. The patient stated that Aleve does helped the pain, but it would awaken him at night and does not resolve until the morning when he was able to get up and move about. The patient has not discussed it with his physician but was encouraged to do so during call. The patient denied to provided healthcare professional information at the time of reporting.