chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-AUG-2013, the patient received his first dose of GARDASIL 9 (route of administration, lot # and expiration date were not reported). The patient received his second dose of GARDASIL 9 on 30-OCT-2013 and the third dose on 06-MAR-2014. On an unknown date, the patient experienced multiple sclerosis. The outcome of multiple sclerosis and the relatedness between the adverse event and GARDASIL 9 were not reported. Upon internal review, the event of multiple sclerosis was considered to be medically significant. Additional information has been requested.
The morning after receiving the vaccine, I woke up feeling under the weather. I took my temperature and received a reading of approx. 102F. I waited 15 minutes, rechecked, and received the same result. I took Tylenol (1000mg PO) and rested on the couch. Throughout the day, my fever continually rose and, at one point, I spent over ten hours with a fever over 104.5F (despite continual doses of Tylenol and ibuprofen). I did a Telehealth visit with a provider who said that as long as I was conscious and not hallucinating, I was able to stay home -- otherwise he recommended I immediately call 911. Thankfully, though my temperature was very high, I didn't need additional medical care. My wife said I slept 34 hours in the 48 hours after receiving the dose. By Monday morning, though, I was able to return to work as my symptoms had nearly fully resolved.  I have a primary immune disease (Common Variable Immune Disease) and, speaking with a healthcare provider I see at the NIH, they believe this reaction was likely caused by the vaccine reacting with a dose of IVIG (Gamunex-C) that I received the day before my vaccine. Their working theory is that there were fresh COVID antibodies in the IVIG and the vaccine reacted to those antibodies.
No known adverse effects.; an administered dose of ROTATEQ underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 23-APR-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660943, expiration date 05-NOV-2020, strength and route were not reported) for prophylaxis.    Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 21 degree Celsius for 19 hours. There was no previous temperature excursion reported. The digital data logger was involved. No known adverse effects.
Swelling/bruising at vaccine site day of vaccine; Hives on hand 1-2 days after vaccine. Swelling of Left knee joint, ankle joint and left foot at day 3. Symptoms resolved by day 5
CVA while at work. Brought in by ambulance, tpA administered with reduction of NIH score from 25 to zero within 6 hours of onset.
have cancer; ever since I received the vaccine my legs hurt so bad; I can't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 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; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset Jan2023, outcome "unknown", described as "I can't walk"; PAIN IN EXTREMITY (non-serious) with onset Jan2023, outcome "unknown", described as "ever since I received the vaccine my legs hurt so bad"; NEOPLASM MALIGNANT (medically significant) with onset Jan2023, outcome "unknown", described as "have cancer". The patient asked wanted to know when this will go away. She have cancer, and many problems, and ever since  she received the vaccine, her legs hurt so bad and she can't walk. She wanted to know if this is one of the side effects and if it will go away. The patient mentioned that she can't go anywhere. She received a Pfizer Booster Vaccine 8 days ago. She also mentioned her Health Care Provider just retired so she is having a tough time.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
EKG showed a-fib following first and second shot. Cardioversion successful. 08/09/2021 Booster received 11/01/2021 Back in a-fib 11/05/2021 Cardioversion 12/16/2021 Back in a-fib 01/20/22
Patient received vaccine on Tuesday.  On Wednesday around 11 am started to feel tingling in the pinky and ring finger of right hand. The tingling and numbness started in her fingers and outside part of her hand and gradually started to go up her forearm and into her elbow. Besides tingling and numbness, she can't use her hand well. She states she has less strength and can't pick up things as normal.
11/20/08 Hep vaccine administered.  11/21/07 patient reported to work feeling nauseated & advertently threw up multiple times V.S.  Labs-WNL.  She reported that she is not pregnant.  N/V resolved 11/21.  c/o "metallic & acidy" taste in her throat & mouth 11/23.
Redness, tenderness, pain, hardness, heat at the 'left deltoid', temp of 101. Headache, muscle ache and body ache. Treated as an out PT w/Keflex in progress.
took the vaccine with the purple cap however she tested positive; she tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "took the vaccine with the purple cap however she tested positive"; COVID-19 (medically significant), outcome "unknown", described as "she tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states she received the first dose of the Pfizer COVID vaccine on 5-5. Patient states she has the feeling of her throat closing on 5-5, but then resolved into a sore throat which has affected her eating. Patient woke yesterday with urticaria allover causing itching and a burning sensation. Patient has been taking Benadryl and using hydrocortisone cream with little relief of itching, but no relief of the urticaria. Patient denies changes in lotions, soaps or detergents. Patient has not eaten anything new. Patient states the only thing different recently was being put on Bactrim and Keflex for an abscess on 4-30. Patient stopped taking the antibiotics yesterday when she saw the rash.  Patient received the vaccine at pharmacy.
tingling sensation on chest and eventually went up to left side of the neck and left side of the face.; Tightness in chest; Pressure in chest; numbness in chest; This is a spontaneous report from a contactable other healthcare professional. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 14Mar2021 (at the age of 32-years-old), as a first single dose for COVID-19 vaccination. The patient's medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Xanax (MANUFACTURER UNKNOWN), Motrin (MANUFACTURER UNKNOWN) and Zofran (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Feb2021 at 22:00, the patient experienced tightness, pressure and numbness on chest 9 hours after vaccine. On 15Feb2021, the patient still had numbness and tingling sensation on her chest and eventually went up to her left side of the neck and left side of the face. The patient did not receive any treatment for the adverse events. The clinical outcome of chest tightness, chest pressure and tingling sensation was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as since 11-OCT-2016), the patient was vaccinated with improperly stored VARIVAX lot # M025871, expiry date: 24-MAY-2018, 0.5 ml, subcutaneously. It was reported that the vaccines were exposed to a temperature of -14.81C for 12 minutes, and -13.31C for 35 minutes, and a previous excursion on 11-OCT-2016 of -12C for 20 minutes and -6C for 45 minutes. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Reporter's 2 y/o son exp a low grade fever & tinnitus following immun;
Pt received vaccine in L deltoid but noticed reaction in R deltoid; after scratching area (lesion) darkened. Seen by medical center.
12/8/2021 8:20 AM: Upper lip swelling and rash/itching to neck area.  Began using  Benadryl on 12/8/2021.   At this time has minimal swelling  of lip and minor rash to neck.
PATIENT SAYS SHE GAVE BLOOD AT MD OFFICE THE SAME DAY AND DUE TO TINY VEINS, THEY TRIED IN RIGHT ARM AND THEN MOVED TO LEFT. SHE RECEIVED HER SHINGLES VACCINE IN THE RIGHT ARM AS WELL. SHE IS UNSURE AS TO WHETHER THE ATTEMPT AT THE BLOOD DRAW  OR THE VACCINE HAS CAUSED A "FLUTTERING" IN HER RIGHT ARM. SHE STATES IT IS ABOVE THE ELBOW, UNDER BOTTOM. SHE SAYS SHEWILL FOLLOW UP WITH HER MD.
Pain and stiffness starting right side of neck, radiation to mid shoulder blade.  No redness, swelling, pain to site of infection, deltoid or arm.
Patient administered  Moderna instead of Pfizer as 2nd dose of primary Covid vaccine series.
Second dose: creatinine level went up to 20-25%; After his second dose he felt tired; little bit of swollen arm went away after 2 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised.; "Diabetes" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised.; "immune compromised" (unspecified if ongoing), notes: history of chronic kidney disease (numbers show in the middle of phase 2 to 3, diabetes and immune compromised. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid 19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "After his second dose he felt tired"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "little bit of swollen arm went away after 2 days."; BLOOD CREATININE INCREASED (non-serious), outcome "not recovered", described as "Second dose: creatinine level went up to 20-25%". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood creatinine increased.  Additional Information: Caller reported history of chronic kidney disease (numbers show in the middle of phase 2 to 3), diabetes and immune compromised. Caller stated that he was fine after the first Pfizer BioNtech covid 19 vaccine. After his second dose he felt tired little bit of swollen arm went away after 2 days. Also reports that he was tired for 3 days after booster shot, also took flu shot at the same time but then felt ok. Also his creatine level went up 20 to 25%, made some medication changes after 2 months kidney levels got better, came back to the number we had before. Caller then got his booster shot 2 weeks ago on 02Oct2021 and his blood test from this Friday showed that his creatine is up about 22% again. He is not feeling tired as he normally is with kidney issues. Caller stated he got the Pfizer Covid, the first shot, and he took the second shot and noticed that his creatinine level went up 20-25% after the second shot. Caller states he went to his kidney doctor and he did nothing, just said to give it a little time. He states after 2 months, it came back, the kidney levels got better, so they think it might have been a side effect of the Pfizer vaccine. He stated he took the booster 2 weeks ago and his creatinine is up 22% again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT HAD JANSEN COVID VACCINE IN MARCH, VACCINATION RECORED WAS NOT CHECKED BEFORE PT MADE APPOINTMENT FOR MODERNA VACCINE. AT THIS TIME PT HAS HAD NO SIDE EFFECTS PT WAS MONITORED FOR 15 AFTER VACCINE
Local reaction to R upper arm. Redness to area and patch about 4in x 3in erythema. No tx. necessary only observation and apply or take Benadryl.
A non-serious report of fever, vomiting, chills, sore throat, and runny nose has been received from a nurse concerning a 10-year-old female, subsequent to FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 25-Nov-2008. On the next morning, the patient woke up with symptoms of fever, vomiting, chills, sore throat, and runny nose. Outcome for the events not reported.
Itching at the injection site from 07JAN22 - 13JAN22. Redness and swelling at the injection site for 1 week following vaccination. Patient did not take any treatments or seek medical care for this event. Symptoms eventually subsided.
BY 4 PM, I HAD TEMPERATURE OF 100,7 DEGREES  SINCE THEN, I HAVE ALTERNATED BETWEEN CHILLS (SHAKING) AND FEVER  TEMPERATURE WAS 99.7 TODAY AT 4 PM. HAVE ONLY  BEEN ABE TO EAT SMALL PANCAKE AND DRINK WATER AND JUICE.
Sore arm for two days Beginning about 12 hours after the shots, shivering (presume a fever, but didn't check) for about two hours, general misery/trouble sleeping for about 6 hours, totally cleared up about 20-24 hours after start of symptoms
Administration of the Shingrix vaccine was painful; Swollen glands underneath left arm pit; Tingling down her left shoulder; Felt pulsating pressure down her left arm; Stiffness in left hand; Numbness in left hand; This case was reported by a consumer via call center representative and described the occurrence of pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 15th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Influenza vaccine Quadrivalent 2021-2022 season. On 15th November 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand. On an unknown date, the outcome of the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand were not recovered/not resolved.   It was unknown if the reporter considered the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine into the left arm, at the same time she received her Flu vaccine in the right arm at pharmacy.  The patient reported that the administration of the Shingrix vaccine was painful. The patient also reported after the vaccination, she began to experienced swollen glands underneath her left arm pit and tingling down her left shoulder and she felt pulsating pressure down her left arm into her pinkie and ring finger and that she felts stiffness and numbness in her left hand. These above adverse events had been going on for over a week and they were currently unresolved. The patient stated that she had no effects in her right arm, the arm she received the Flu vaccine. The patient also received covid booster vaccine on 4th October 2021 and that was administered in her left arm. The reporter did not provide the lot or expiration date of the Shingrix vaccine. The reporter consented to follow up.
This is from the patient, "sensation of momentarily not being able to control my left arm as I could only raise it a few inches. I thought my speech was slurred and sounded funny for about 3-5 seconds. My tongue on the left side felt enlarged. My husband who was in the car next to me did not notice anything."
Rash on/near the injection site pt stated it was itching - that's when she noticed the rash. Patient took BENADRYL.
This spontaneous report as received from a nurse, refers to a patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, ten patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot # L005293, expiration date: 17-AUG-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further details were provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Patient received the pediatric formulation instead of the teenage/adult formulation. This 15 year old received 10 mcg of mRNA Pfizer instead of the recommended 30 mcg mRNA Pfizer  for 12 and over.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that an unspecified number of patients received GARDASIL injection 120 Y and oral ROTATEQ that were exposed to 51F (Fahrenheit) for 22.8 hours, which was an excursion that was found to be unsupported by in-house stability data. No adverse symptoms reported. No further information provided. Additional information has been requested.
Fever 102  all nigh and the next day; Severe arm pain; under arm pain; breast pain; neck pain; chills; tired; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 18:00 (Lot number: FH8028) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "NO" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Fish oil, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 16Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 06Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 18:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Fever 102  all nigh and the next day"; PAIN IN EXTREMITY (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Severe arm pain"; AXILLARY PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "under arm pain"; BREAST PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "breast pain"; NECK PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, axillary pain, breast pain, neck pain, chills, fatigue.  No follow-up attempts are possible. No further information is expected.
Weakness of the hands; Muscle weakness; Memory is "funky"; Slow speech; Unable to stand; Difficulty swallowing; Lost a lot of weight; Not eating; Rashes all over the body; Feeling tired all the time; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech) and DYSSTASIA (Unable to stand) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0308218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight), RASH (Rashes all over the body), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site). 04-Apr-2021, the patient experienced DECREASED APPETITE (Not eating). At the time of the report, MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site) had not resolved, DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight) and DECREASED APPETITE (Not eating) outcome was unknown and RASH (Rashes all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amino acid level: high (High) high. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Protein total: high (High) high. On an unknown date, Protein urine: high (High) high. On an unknown date, Red blood cell count: 4.48 (Low) 4.48. On an unknown date, Urine analysis: normal (normal) normal.         No treatment medications were reported.