chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates starting on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L040458, expiry date 04-FEB-2018, strength, dose, route and dose number were not provided). The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient received the GARDASIL 9 injection (exact dose, route of administration, lot # and expiration date were not provided) series as follows: the first dose on 07-JAN-2016, the second dose on 11-MAR-2016, and the third dose on 11-MAY-2016. There was no adverse effect reported. Additional information has been requested.
Case number PHHY2012US013454 is an initial literature report received on 14 Feb 2012. Authors published the adverse events following administration of H1N1 vaccine to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a fetus (unknown gestational age) of a pregnant female patient. At an unknown gestational period the pregnant female patient was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 and 28 Feb 2010 (see linked case: PHHY2012US013454). On an unspecified date fetal adverse event of tachycardia was noted. The outcome of the event was not reported. The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1 with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes.
rash about the size of a baseball that both itched and was irritated. Nausaus
No additional AE reported; Nurse reporting a temperature excursion for GARDASIL9 RECOMBIVAX ROTATEQ VAQTA that occurred on 12/16/2022 states it is unknown at time of call if any products have been administered.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information regarding the patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies provided.  On unspecified date, the patients were vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, route of administration, vaccination scheme were not provided; lot number 1775808 that was verified to be valid, expiration date reported and established as 20-AUG-2023); hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023);hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023) (strengths, doses, routes of administration and vaccination schemes were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration, at a dose of 2 ml (lot number 1837117 that was verified to be valid,  expiration date reported and established as 3/24/2023) (strength and vaccination scheme were not provided)(product storage error). All of the vaccines were administered as prophylaxis.  The administered doses of the vaccine were stored at a temperature of 27.03 degrees Fahrenheit (F) during a time frame of  6 minutes, and it was mentioned that the temperature excursion occured on 16-DEC-2022. There was no previous temperature excursion. No additional adverse events were reported.    Follow-up information has been received on 24-FEB-2023.  Patient's demographics have been provided, referring a 13-year-old female patient. Suspect vaccine was updated to only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), vaccination anatomical location left deltoid.
first dose / on 3/22/2018 / never able to get the second dose; arm was sore for 5 days at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient's arm was sore for 5 days at the injection site after the 1st dose. The patient was never able to get the second dose. Till the time of reporting the patient had not received 2nd dose of Shingrix which led to incomplete course of vaccination.  The reporter consented to follow up.
Broke out in hives to back. No respiratory involvement. No swelling to face. Occurred about an hour after injections. Father stated that he had not eaten anything after shots were given.
Patient received the Pfizer vaccination on 3/17/21 and 4/7/21. Patient presented to ED with CP related to increased SOA.  Patient stated that she had tested positive for Covid-19 on January 5, 2022 and subsequently admitted to Hospital for 3 days and discharged.  .
This spontaneous report was received from a Registered Nurse (R.N.), referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 12-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, intramuscularly, lot # M011117 and exp. date 07-DEC-2016. Anatomical location was not provided. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
4/18/21 pfizer shot in left arm. 8 hours later nausea, heart race, dizzy. go to sleep. wake normal. no more symptoms for 10 days. Day 10, arm pain returns at the injection site. Day 20 arm pain has spread in size and pain, i cancel the second shot. elbow and wrist become inflamed, tight, pain restricted. become sick for 5 days, headaches exhausted.  prescribed 40mg prednisone for 5 days. first day it took the swelling down, then swelling came right back 2nd day. pinky and ring finder go numb, paresthesia/paresis. nerve pain in forearm to hand. ulnar nerve at first then all fingers. arm injection pain throbbing. rash shows up on stomach (now at 3.5 to 4 weeks since shot) cannot grasp a cup, weakness and numbness in hand. At this time its confined to the injection arm. Over the next week nerve pain and numbness spread to left side of face, both arms, hands, fingers, legs, feet, toes. physical therapist confirms elbow lymph node on injection arm swelling, hands turning red extreme pain and swelling, loss of feeling. nerve pain in the entire body, nerve and muscle spasms in all parts of body. Fingers and does burning at the tips feel like a string is cutting off circulation. Visibly red. Around the 4 week mark, fully unable to lift legs or arms, left half of face numb, zap/jots seizure like hitting my body. go to ER seemingly becoming paralyzed,  within hours strength of legs returns but with numb feet/toes. no diagnosis other than peripheral neuropathy. neck begins to swell, hurts to swallow, throat closing. trying to sleep, throat closed, wake up, completely unable to open throat cant breath. throat episodes lasted about 5 days and resolved. complete insomnia and 24/7tinitus. any attempt to sleep or become tired results in heavy body zaps like hooked to a tenz unit. can't use hands or type, arm to hand seized nerves, feel like shrunken or contracted nerves. PCP prescribes benzos to sleep. this allows some sleep with waking every hour. over the following weeks symptoms seem to improve slowly but still debilitating. today at week 8+ since one shot only, I am able to type again, but with nerve pain and numbness in all fingers. loud tinnitus, numbness in all limbs, episodes of extreme debilitating muscle fatigue come in waves, almost unable to stand agonizing muscle fatigue and nerve zapping. These full body muscle episodes only seem to come in waves of 24 hours, then seem to feel recovering, only to relapse again. injection site pain seems to have wrapped around to the bicep 24/7 pain. unsure if this is nerve or muscle. 3 ER visits, PCP visits, blood tests, no help. I cannot work, constant nerve firing muscle spasms and nerve pain and episodes of weakness so bad you cannot sit without agonizing pain. I am disabled from this and still searching for help
Left arm swelled, red, itchy, tender 1 week after injection. Only sore the day or 2 after injection snd then the symptoms started one week to the day of the shot
Patient presented 24 hours following vaccine administration with fever of 102.8.  Patient denied any symptoms other than malaise which she attributed to fever.  Patient instructed to take Acetaminophen 325 mg 2 tablets q4-6 hours PRN fever.  Patient seen for follow-up the following day and had been afebrile since early that morning.
On the 9th day following my Moderna vaccine, I developed a large raised and itchy rash at the injection site on my left arm. This began to fade after 2 days.
Mid-April, I started getting a lot of leg cramps, in my lower calves and into my feet. My feet curl up.  I must walk a lot, to try to walk it off, but it is tight muscles. When I am lying in bed and I try to stretch, my feet start cramping up.  I mentioned it to my doctor, but no one seems to concern.  Dr. gave me medicine, Ropinirole hcl 2.5 mg, 2 at bedtime. The medicine has relieved it some. It does help, the pain does not last as long. I drink a lot of water. I tried electrolytes. I have tried everything. I have not recovered from the AEs.
On  4/2/22, pt's mother first noticed a vitiligo patch over the pt's right eyelid, I examined this pt on 4/7. She has no history of vitiligo. This provider did not notice this spot on the date of vaccination. Pt has been referred to dermatology.
SINUS WITH HEADACHE; DROWSINESS; FELT ACHY; SOAR ARM AFTER VACCINE; BRUISE ON THE ARM /COLOR BLUE; 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, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced bruise on the arm /color blue. On 28-MAY-2021, the subject experienced soar arm after vaccine. On 29-MAY-2021, the subject experienced felt achy. On 31-MAY-2021, the subject experienced sinus with headache. On 31-MAY-2021, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruise on the arm /color blue, and soar arm after vaccine on 01-JUN-2021, had not recovered from sinus with headache, and drowsiness, and the outcome of felt achy was not reported. This report was non-serious.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 03/25/2021 and 04/22/2021. They became symptomatic on 11/25/2021 with symptoms of cough, temperature [fever], and fatigue. The individual was a resident of a skilled nursing facility. They tested positive at this skilled nursing facility on 11/25/2021. They died on 11/28/2021. I see no indication that the individual was hospitalized related to this illness. The death certificate lists Multi-System Organ Failure and COVID-19 in Part I (Cause of Death).
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer NOS. Concurrent medical conditions included Fish allergy, Shellfish allergy and Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVASC), ATENOLOL, CALCIUM, IRON and GABAPENTIN for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-416295 (Patient Link).
Initial report was received on 19 July 2012 from a healthcare professional which involved a cluster of two infant patients who had received PENTACEL, lot number C4144AA. One of these two patients (not specified) had also received a second dose of PENTACEL (lot number C4165AB). This case captures one patient. The other patient has been captured in case number 2012-07019. A six-month-old patient (sex and date of birth not reported) had received an injection of PENTACEL, lot number C4144AA (route and site not reported; date of administration unknown) and an unspecified amount of time later, the patient was hospitalized and diagnosed with Pertussis. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
pt rcvd vax; grunting noises; baby blue around mouth & very pale color; distended stomach & full of gas;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 17-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route were not specified) for the long-term prevention of shingles and zosterrelated conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
This spontaneous report as received from a consumer refers his male friend of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (Lot # not reported) in the back of his arm. No other co suspects were reported. No concomitant therapy was reported. On an unknown date, the patient experienced soreness at the site of insertion. The outcome of having soreness at the site of insertion was unknown. Additional information is not expected.
I have a 99.98 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13th November 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked how long would fever last after getting the shot. The patient had no fever this morning but the patient had a 99.98 degree F fever at the time of reporting.
nausea; chills; headache; low grade fever; muscle aches; could not eat; but still very tired; dizzy when standing; blurred vision; It is now the 8th day since shot and still weak not quite well, but better; It is now the 8th day since shot and still weak not quite well, but better; Was ill for 6 days; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient reported for herself) reported that a 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included tested positive for covid from 30Dec2020; obese. The patient's concomitant medications were not reported. Customer reported was tested positive for covid on 30Dec2020. She had a very mild case. First Pfizer shot, 04Mar2021. In Mar2021, the patient was ill for 6 days. In bed first 3, with nausesa, chills, low grade fever, headache, muscle aches, could not eat in Mar2021. 4th day better, but still very tired and dizzy when standing, blurred vision in Mar2021. It was now the 8th day since shot and still weak, not quite well, but better in Mar2021. The patient did not want second dose. Terrible reaction to the first injection. The outcome of Weakness and Feeling unwell was recovering, of the other events was unknown.    Information about batch/lot number has been requested.
Initial report received from a nurse on 16 Dec 2009. This patient (a 3 year old boy) was vaccinated with FLUVIRIN (batch no: 100814P) on 14 Dec 2009. No adverse event was reported.
The patient had symptoms of syncope starting about 5 minutes after the vaccine was given. She lost consciousness briefly twice, was dizzy, lightheaded, weak, and sweating. She was placed in a flat position with her feet elevated on a chair. We called 911 and the ambulance came after about 20 minutes. At this point she stated she was feeling much better, and was taken in the ambulance for further observation.
SORE THROAT - ONGOING COUGHING  - ONGOING FEVER - 100 DEGREES POSITIVE COVID TESTS - DAILY ALL POSITIVE
Day 8 post vaccination a rash/hives developed under the injection site. Signs and Symptoms: redness, itching, swelling.
Random bruising has developed on arms, legs, hips; This is a spontaneous report received from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK10158) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patient had penicillin allergy. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 10Apr2021, the patient experienced random bruising which developed on arms, legs and hips. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event random bruising which developed on arms, legs and hips were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bells Palsy on right side of face; Headache; fatigue; sore right arm(injection arm); This is a spontaneous report received from a Pfizer sponsored program . A contactable consumer (patient) reported that a 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in the right arm on 21Feb2021 at a single dose for COVID-19 immunization. Medical history included 20 years ago (in 2001), he had Bell's Palsy on left side of face which was more severe, he had lost his hearing and the paralysis was present for a long period of time. The patient's concomitant medications were not reported. The patient had a sore right arm (injection arm), headache, and fatigue after the vaccine (unspecified date in 2021). On 02Mar2021, 10 days after the first dose (as reported), he developed Bell's Palsy on right side of face. He has been put on prednisone by his MD to treat the Bell's Palsy that he was currently experiencing. He was on Prednisone for Palsy and wondering if it could decrease efficacy of vaccine. He wanted to know if the second dose is going to create a problem with the Bell's Palsy. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
vomiting. presents with chill, HA, vomiting over 10hrs since got COVID vaccine. can't take fluid down. denies took meds at home. HPI:22-year-old male with chief complaint of vomiting headache and body aches.  He received the J&J vaccine yesterday.  He reports around 2 AM he woke up with persistent vomiting.  He was unable to even keep down liquids.  He denies any abdominal pain.  He denies any fevers or chills.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot #L044694, expiry date: 04-FEB-2018, lot #L044707, expiry date: 06-OCT-2018) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 53.3 F for a time frame of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
The first night the left arm muscle became very enlarged, red, and tender to the touch. The patient said it hurt to move arm and she iced it overnight. On 09/30/2017, the muscle had gone down but the redness had spread to the size of a potato and was still tender and still hurt to move and took a Benadryl. This morning on 10/01/2017, the patient came in and showed me the site and was still red and the size of a potato. Said she could move her arm freely and the redness was getting better and starting to itch. She said she was taking Benadryl for the redness.