chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/7/99:Pt. rcvd 1st dose of Hib,DTP,& OPV.Within 2 days, developed an injection site reaction characterized by blistering skin lesions.The injection site was postive for Staphylococcus, and subsequently was hospitalized.
Fever and chills (severe shaking) starting around 5 p.m. on the day of the vaccination (Feb. 10).  Took 2 Tylenol around 9:30 p.m. and went to  bed.  Had a temperature of 100.2 on Feb. 11; no chills.  Stayed in bed the whole day.  By about 5 p.m. the fever was gone and I was feeling much better.  Today (Feb. 12) pretty much back to normal.
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: shingles).  The outcome of the shingles was not reported.   The reporter considered the shingles to be possibly related to Shingrix.     The company considered the shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 This case was reported by consumer via interactive digital media. The reporter was a patient and reported that she got a shingles a week after she got vaccinated for it. The reporter reported that she found out it took more than a week for it to work. The reporter reported that she did not get it too bad though.
RECURRING CHEST PAINS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced recurring chest pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring chest pains. This report was non-serious.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Evening of receiving injection was nauseous and threw up, had the chills and sweats. Could barely eat for the next four days and felt extremely weak. Monday 9/6/21 felt extremely weak still, heart started racing, chill, sweats, left side of face went numb/tingly, fingers tingly, chest pain on left side, nauseous. Extreme fatigue for next three days along with nausea, vomiting, diarrhea and sore throat. Began to feel slightly better on Saturday, 9/11/21.
swelling; hardness at injection site; injection site is warm to touch; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years old and unknown gender patient who had swelling, hardness at injection site and injection site is warm to touch after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  suspension for injection  (strength was unknown, lot C5816AA and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of swelling ,hardness at injection site (vaccination site induration) and injection site is warm to touch (vaccination site warmth) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events ( swelling, hardness at injection site, injection site is warm to touch).  Outcome: Unknown
.05 ml dose given, instead of .5 ml dose. Patient called back in and .45 ml given, the same day.
Numbness in both upper extremities, sharp stabbing pain in face and eyes followed directly with numbness, muscle spasms, major fatigue, diarrhea, nausea, loss of appetite.
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-NOV-2009, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a medical services facility. On or about 13-FEB-2017, the patient was treated by a healthcare provider at a medical services facility for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Rash on cheek and dryness, redness, swollen - 20 minutes after injection.  Benadryl and some relief noted; at 22:00 tingling tongue, gums and swollen tongue, jaw tightness, small white rash on back at ER difficulty swallowing and blotchy red rash with swelling of arms.  Received Depo Medrol also Pepcid.
On day 5 after injection, patient developed right inner thigh discomfort, leg swelling and accentuation of existing varicose veins.
Information has been received from a certified medical assistant concerning her 11 year old daughter with no past medical history and no allergies who on 15-DEC-2006 was vaccinated with a first dose of Gardasil (yeast), IM. There was no concomitant medication. On 11-JAN-2007 the patient experienced excerise induced asthma. The patient noticed that she was short of breath during exercise during sports. The patient had recovered  without treatment on 30-JAN-2007. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender who on 29-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
pt recvd vax; immed following vax, had an allergic rxn  & devel red face, SOB & pinpoint pupils; tx w/ epinephrine & oth meds;adm to hosp;subsequently recovered & was discharged later in eve;
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Swelling in throat, pressure in head, blood shot eyes, burning in mouth, difficulty swallowing, heavy breathing, severe chills.
This spontaneous report as received from a 25 years old female patient with allergy to CIPRO and none pertinent medical history. On 24-MAY-2012, the patient was vaccinated subcutaneously with a second 0.5 ml dose of MMR II, lot number 669517/0037AA exp date 01-FEB-2013. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified). The patient reported that she received the second dose and on 02-JUN-2012, she experienced swelling under the chin and under the tongue (medically significant, upon internal review). The consumer was still experiencing swelling under the chin and under the tongue and at the time of the report, back of the tongue 3 times a day. The patient experienced this at anytime, whether she was when she first got up in the morning or exercising or eating. The attacks last from 45 minutes to one hour. She was having constricted breathing (medically significant, upon internal review). At the time of report, the patient had food allergies (medically significant, upon internal review), panic attacks (medically significant, upon internal review), her hands and feet were swollen (medically significant, upon internal review), and she got red (medically significant, upon internal review), her vagina swollen (medically significant, upon internal review) and got a yeast infection (medically significant, upon internal review). She had seen 4 different physicians and an allergist. She stated that at the time of report, she was "allergic to all things" (medically significant, upon internal review) and what she was experiencing was causing distress every day (medically significant, upon internal review) and she was a 2nd year graduate student and this was interfering with her life. The patient carried an epinephrine (medically significant, upon internal review) at the time of report, but had not need to use it yet. Prednisone (manufacturer unknown), CLARITIN, PEPCID and BENADRYL was given as treatment for the events. Food allergy test was performed and showed that the patient was allergic to almost everything, some food given were eggs, nuts, melon, mustard, tomatoes, peas, beans, everything in the legume family. Blood test was also performed and was normal. Ultrasound of throat taken showed slightly enlarged but normal. At the time of report, the patient had not recovered. Additional information has been requested.
1330- report received from RN. Patient continues to report itching on face, entire back and upper right arm, which has spread from initial mid back. Rash noted on chest, right arm, on face (specifically cheeks), and lower back.  Patient states after receiving first Bendryl 25 mg dose given by RN, no changes or improvement noticed. Patient given Benadryl 25 mg PO. Doctor aware.    1345- BP 141/82 HR 90 RR 18 98% SpO2 on RA  1355- patient has new c/o dull headache. Doctor notified. Per Doctor, continue to monitor at this time.  1405- patient states feeling improvement with itching. "it's not as itchy as before". Will continue to monitor. 1430- patient states "just slight itching now". BP 127/76 HR 89 98% SPO2 on RA RR 18. Per Doctor, to educated patient before she can leave back to work. Patient educated on returning for care in ED or Urgent care if symptoms worsen. Patient agree to this.  Patient discharged from the observation area at this time.
Fever of 101.5 degrees F presented on 10/08/14 after child woke up.  Fever persisted until 10/10/14 at approximately noon.  On 10/11/14, red bumps appeared on child's neck and chest area.  Within 24 hours, child was covered head to toe in red bumpy rash.  Rash also coincided with lethargy and loss of appetite.  Was taken to Pediatrician 10/13/14 at 9:00AM, confirmed reaction to MMR vaccine by Pediatrician, currently rash is still present (10/13/14).
3 days, post vax, pt began to wheeze. Cried for 2 days on and off after injections. Prior to this visit, had not been sick with a cold, not even a runny nose and had no wheezing prior. Had stiff sore leg 5th day, post vax, and developed croupy cough, 9th day was admitted to the hospital. Received breathing treatments 2 days then sent home with nebulizer. Now wheezes with slightest colds. Was dx'd with Hyper Airway Disease. Was gaining on average 1.5 to 2 lbs. a month before this onset, now has stopped eating, growing and has only gained 2 lbs. in 12 months. Failure to thrive-unknown cause.
Pt. states that the arm where she received the Pneumovax (right arm) started to swell and get warm to touch and is painful. No stridor, no rash all over the body and no resp. distress. No fever or chills.
Persistent pain 4+ weeks post vaccination. No signs of infection. Only hurts when lifting arm to about shoulder height & higher. Does not bother at rest, only when raised.
This case was reported by a physician via sales rep and described the occurrence of multiple sclerosis in a 17-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included HAVRIX for prophylaxis and GARDASIL for prophylaxis. The patient's past medical history included seizure (had an episode of seizure at the age of 4 years old). On an unknown date, the patient received BEXSERO, HAVRIX and GARDASIL at an unknown dose. On an unknown date, 7 days after receiving BEXSERO and HAVRIX, the patient experienced multiple sclerosis (serious criteria GSK medically significant) and numbness generalized. On an unknown date, the outcome of the multiple sclerosis and numbness generalized were unknown. It was unknown if the reporter considered the multiple sclerosis and numbness generalized to be related to BEXSERO and HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO, HAVRIX and GARDASIL on the same day. After a week of vaccination, the patient ended up at emergency room with numbness throughout the body. The patient was diagnosed with multiple sclerosis at the hospital. Upon finding it was noticed that the plaque with multiple sclerosis was old. As per physician it was believed that the immune response of the vaccine might have triggered the multiple sclerosis that was dormant in the body. The physician was in contact with the neurology department and was waiting for the final results. There was no diagnosis of multiple sclerosis prior to receiving the vaccine. The patient had been discharged from the hospital (no further details provided). It was unknown if the reporter considered the multiple sclerosis and numbness to be related to GARDASIL as well. No further details were provided.
R arm itching, redness, swelling, warm to touch started 1/3/21. Received COVID (Moderna) vaccine on 12/28/20. Declined med tx. Report only.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of her friend. The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206160, US2019205723 and US2019205719, reported by same reporter.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment medications were reported.
Shot given by pharmacist on site.  Soreness and tenderness at injection site started first, then chills, muscle and joint pain, severe headache, lethargy, all started 3 AM on 4/18/23.  Chills, muscle and joint pain, headache and lethargy/malaise continued for 2 days. Those symptoms subsided except headache which went away after 4 days.   Arm tenderness at injection site and a lump continued and noticed a 3 inch diameter redness around injection site along with itching.  Reported to clinic triage nurse on or about 4/21/23, and was told to come into urgent if worsened on 4/22/23.  Redness and lump, and itching moved towards armpit and down inside of arm, but redness went away. Was told by triage nurse to observe for cellulitis.  slight swelling on upper arm and itching is still present, but redness is gone as of today, 4/27/23.
Fever of 102.1. 4 runny diapers, small green circle above naval size of quarter.
Vaccinated at work pharmacist experienced tightness in chest beginning 10/21 approximately 6hrs after injection. Off and on up to today - 10-26. All over body itching beginning 10-24 hrs till today - still itches.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of GARDASIL lot number reported as M044717 with expiration date of 19-JUL-2017, lot number reported as N007931 with expiration date of 17-NOV-2019, and lot number reported as M041990  with expiration date 28-JUN-2019, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported).  The administered doses experienced a temperature excursion of 60 degree Fahrenheit for 4 weeks; data logger was involved. No previous temperature excursion was reported. No adverse events were reported and no product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009560: US-009507513-1709USA008052:
Vaccine exposure during pregnancy; Hypothyroidism; This is a spontaneous case from, initially received from other health professional on 10-Feb-2020 with additional information received on 12-Feb-2020, being processed together, concerning a pregnant female patient (Race and Ethnicity: not reported) of unspecified age.  The patient's medical history and concomitant medication included were not provided.   The patient's obstetrical history, history of offspring with major congenital malformation (MCM) and relevant maternal and paternal medical history were not reported. It was not reported if mother used tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was not reported. The patient's estimated delivery date (EDD) was reported and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On 25-Sep-2019, approximately at 28 weeks of gestation, the patient was administered Afluria QIV [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an unknown indication.   On an unspecified date in 2019, the patient developed hypothyroidism, reported as pregnancy complication.  Approximately at 37.1 weeks of gestation, the patient delivered live birth female neonate by caesarean method. The neonate's birth weight was 3430 g, length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (one minute) and 9 (five minutes). There was no APGAR score data for 10 minutes reported. No MCMs were identified at birth.  At the time of this report, the outcome of the event hypothyroidism was not reported.  The event of hypothyroidism was considered as serious due to the criterion of medical significance, per company.  The causality assessment was not provided.  Company comment: It is unknown when the patient developed hypothyroidism therefore the causal relationship between Afluria and this adverse event is considered unassessable. Vaccine exposure during pregnancy is causally unrelated to Afluria.; Sender's Comments: It is unknown when the patient developed hypothyroidism therefore the causal relationship between Afluria and this adverse event is considered unassessable. Vaccine exposure during pregnancy is causally unrelated to Afluria.
facial tingling, sensation of throat itching and swelling within a few minutes after the injection. Lasted 1-2 days thereafter. No facial swelling or respiratory distress.
fever 100 degrees, coughing, loss of motivation, and sense of imbalance to some degree. But most importantly, my double vision, was substantially worse after this shot.  In hindsight, my prescription changed drastically, after first shot.  But now, my corrected glasses, do not correct enough, after being increased, after the first shot.  my double vision is likely due to muscular damage, and damage to the skeletal cage of the eye, when younger.   So my guess is, this has affected the injured muscles.  As my eyes, often reflect, whether I am sick.   Also during the time with fever,  my eyes felt like there was a lot of pressure.  My double vision, is not linear.  Just below the horizon, my double vision is correctable.  But as I raise my eyes, to the horizon, and then above, the problem increases significantly. The eye problem remains after two weeks.  I had double vision for years, without really knowing it. I thought it was normal. But as it got worse, I was forced to deal with it, as a problem.
PT STARTED FEELING PAIN IN RIGHT ARM THE EVENING OF THE COMPELTION DOSE. THE FOLLOWING DAY, SORNESS AND PAIN SET IN AND TRAVELED DOWN THE ARM. THE PATIENT WAS IN SUCH PAIN THAT SHE DIDN'T WANT TO USE HER ARM. NO BRUSING OR BLEEDING WAS WITNESSED AT THE INJECTION SITE UPON REMOVAL OF THE BAND AID. PT REPORTED FEELING VERY TIRED AND WANTING TO SLEEP FOR 5 DAYS AFTER THE VACCINE. PT ALTERNATING TAKING IBU AND APAP UNTIL RESOLUTION.