chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of chills in a 61-year-old male patient who received Shingrix (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Concomitant products included Shingrix. On 6th September 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th September 2018, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In September 2018, the patient experienced chills, fever and pain. On 7th September 2018, the outcome of the chills, fever and pain were recovering/resolving. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills, fever and pain to be related to Shingrix. Additional details were provided as follows: On 30th July 2018, the patient received 1st dose of Shingrix (intramuscularly) (batch number 7X3EJ) in left deltoid. The patient received 2nd dose of Shingrix on left deltoid, about 6 weeks after his first dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule between 1st dose and 2nd dose. The physician thought that there might had been a computer flagging error that contributed to the patient receiving the dose early (rather than waiting the recommended 2-6 months). Following the 2nd dose of Shingrix within hours of administration, the patient developed aches and fever. Within 24 hours after receiving 2nd dose of Shingrix, the patient experienced large amounts of chills and rigors. Till 7th September 2018, the patient continued to experience large amounts of chills and rigors.
Within 12 hours of vaccination, noticed lathargy, increased fever, and development of a red rash surrounding the injection site.  Rash increased bilaterally to include posterior scapular, humeral, radio-ulnar regions along with rash at the dorsal digital region of the hand extending between the fingers.
Vertigo started after lying down the same night of getting the vaccine.  Vertigo continued every night and was accompanied by nystamus upon waking each morning.  Symptoms continued for the first several hours after awakening then would gradually get better and was much lighter during the day.  Would return every night and next morning and this continued for the next 7 days.   My head felt like it was in a fog and it seemed harder to think.  It was also very sinus like.  No nasal congestion, no post nasal drip, no cough, but my head felt thick and full.  I had headaches which I never get.  I took my blood pressure to be sure and it was normal.  I took Claritin (without the D), Flonase alone and then also Dymista, did the Neti pot, and took Ibuprofen.  Headache got better but still had the head fog.  Today is post vaccine day 8 and I finally woke up this morning feeling better.  Hope it lasts but I answered "Unknown" to Item 20 below because it's too soon to tell.
fever; chills; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 23Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of COVID vaccine last 23Dec2020 and she was doing fine. On an unspecified date, she woke up with fever and chills. She wanted to take Xofluza medication to shorten symptoms of flu and she would like to know if there would be an interaction if she takes it with COVID vaccine. She also wanted to know if it is ok to get her 2nd dose of the vaccine which is due next week, 13Jan2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt lied and said she had never had any Covid vaccines.   When entering into system vaccine given 10/1/2021,  saw Pt had Covid-19 Vector-NR (JSN) on 3/8/2021 from Pharmacy.
This case was reported by a physician via sales representative and described the occurrence of injection site abscess in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline), KINRIX. On an unspecified date the subject received a dose of PEDIARIX (unknown details), a dose of KINRIX (unknown details). At an unspecified time after vaccination with either KINRIX or PEDIARIX, the subject experienced injection site abscess (described as "abscess near the injection site"). The physician mentioned that the suspect vaccine was PEDIARIX; however, one of the nurses mentioned KINRIX. No additional details were available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Her vision in her left eye became blurry; Started out as if she had pink eye or conjunctivitis; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization and experienced arm soreness. Nine days after the patient received dose 2 of BNT162B2 (10Apr2021) the patient experienced vision in her left eye became blurry and she couldn't see because it was completely blurry. It started out as if she had pink eye or conjunctivitis. She normally did not wear glasses except for reading but now the vision was blurry. She also had arm soreness on an unspecified date. The outcomes of arm soreness, conjunctivitis, and blurry vision were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the patient got COVID and didn't got the second dose. The patient went back on 06Jun and got another dose.; Had her first dose 29Dec2020 and a week or two later got Covid; Had her first dose 29Dec2020 and a week or two later got Covid; This is a spontaneous report from a contactable pharmacist. An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient had her first does on 29Dec2020 and a week or two later got COVID and didn't got the second dose. The patient went back on 06Jun2021 and received another dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The reporter stated: the patient was here in currently day to got the second dose from the Jun2021 series. And the reporter wanted to known whether that dose could be given. The outcome of COVID and drug ineffective was recovered in 2021 and the outcome of inappropriate schedule of vaccine administration was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
severe shoulder, back, and neck pain and difficulty moving arm.  Pending Xray results.  Given lidocaine patch and Tylenol
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the oiutcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient felt a little sore after the SHINGRIX vaccination. The patient declined to provide contact information or additional details. For further tolerance, refer case US2018089468.
a huge flare up after her first covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): US-AMGEN-USASL2022004607.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL taken for psoriatic arthropathy. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "a huge flare up after her first covid vaccine". Subsequently, her health care professional told her to not get the second one. No treatment information was received. The causal relationship between the event psoriatic arthropathy and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore throat; shiver/ chills; muscle ache; headache; tired; temperature of 100.5; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced sore throat, shivers, muscle pain, headache, tiredness and fever. On an unknown date, the outcome of the sore throat, shivers, muscle pain, headache, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, shivers, muscle pain, headache, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported. The patient received Shingric vaccine and experienced temperature of 100.5 degree Fahrenhiet and chills/shiver, muscle ache, headache, tired and throat hurts. The reporter wanted to know could the shingles vaccine cause sore throat. The reporter was wondering if she should go to the doctor because her symptoms had not yet resolved.
Information regarding PREVNAR 13 was received from a physician assistant regarding a patient (age and sex unknown) who experienced redness, inflammation and skin warm to the touch after vaccine administration. The patient received a dose on an unspecified date. The patient experienced redness, inflammation and skin warm to the touch after vaccine administration. The outcomes are unknown. No additional information was available at the time of this report.
This spontaneous report was received from a medical assistant refers to a three patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients received unspecified improperly stored doses of VARIVAX (Merck) 0.5 ml, lot number L019124, expiration date 27-MAY-2017, (anatomical location were not reported). VARIVAX (Merck) was administered by intramuscular injection, instead of subcutaneous injection. There were not concomitant medications provided. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a female patient (also nurse) of unknown age. On 04-JUN-2014 the patient in advertently splashed M-M-R II in her left eye. The patient sought medical attention in an office. No hospitalization was involved. None laboratory diagnostics were performed. The left eye was splashed with water and was "feeling sticky" at the time of the report (04-JUN-2014). The relatedness between "feels sticky" and M-M-R II was not reported. Additional information has been requested.
not showing any immunity; he tested negative for antibodies/not showing any immunity; His arm was a little sore and he was a little tired; His arm was a little sore and he was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 73-years-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL9262 and expiry date was not provided), via an unspecified route of administration, in left upper arm muscle on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included ongoing blood pressure abnormal, ongoing Gout, CLL ((Chronic lymphocytic leukaemia), It is a blood disorder. He is not on medication for it and is asymptomatic. He has been diagnosed about four or five years), ongoing thyroid disorder and He had a nodule years ago and it was removed. The concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, allopurinol taken for gout, atorvastatin, amlodipine besilate, acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), finasteride, irbesartan taken for blood pressure abnormal and tamsulosin. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL1284 and expiry date was not provided) via an unspecified route of administration, in left upper arm muscle on 15Jan2021 as SINGLE DOSE for Covid-19 Immunization. It was reported that the patient had both doses of Pfizer vaccine, tomorrow would be four weeks since his second dose. The patient reported that his arm was a little sore and he was a little tired for a day or two. Patient had the antibody test on 01Mar2021 (Monday), got the results on 03Mar2021 as negative and reported that it was not showing any immunity. The patient had no vaccines within 4 weeks of getting his COVID19 Vaccine. The outcome of the events reported as unknown.  Follow-up attempts are completed. No further information is expected.
Body is itching all around; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body is itching all around) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Body is itching all around). At the time of the report, PRURITUS (Body is itching all around) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The patient wants to know was this a side effect or an allergic reaction. And whether want to take another dose or not.
An hour after the vaccine, she felt like she had experience heart racing for about 24-48 hours. Little sore arm, not much. I woke up the next day lethargic, tired and groggy. No fever but had chills. I had a bad headache. The next day, still feeling like my heart was racing, bad headache, body aches but starting to feel a little better. On the third, I felt a little more human. Had anxiety, heart racing and a little bit of a headache. By the 4th day, I woke up with a headache. After lunch, I noticed that everything was very bright, and it made it hard to be outside without sunglasses. When I was inside looking outside, it was difficult to look outside. At that time the headache hit very hard and lasted 14 days. It was really severe bad headache. during that time, the pain shot down my neck and into my back. Dr. advised me to go to the ER because the day before the J&J vax had been recalled to due to the blood clots. ER stated headaches were common with the J&J shot and that it was just a side effect but should subside. You began taking ibuprofen as needed. I had anxiety.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fainting, seizures immediately following vaccination. 10/19/09 Emergency Department records received for date of serivice 10/15/09. Dx:  Syncope, seizure, anxiety Assessment:  Seen for syncopy vs. seizure episode.  EEG, Head CT and Echo normal.  Head CT:  No evidence of intracranial process.  Echo:  Normal study.
I had like an electrical shooting sensation going down the inside of both of my arms. I went to the Emergency Room because I thought I was having a heart attack. They ran some tests, and everything came back normal. They told me it was probably stress related and did not prescribe medication. I haven't had any issues like this again either.
BODY ACHE; SORE TEETH; CHILLS; HIGH FEVER TEMPERATURE/103.2 FEVER FOR 4 HOURS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced body ache. On 21-MAR-2021, the subject experienced sore teeth. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced high fever temperature/103.2 fever for 4 hours. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore teeth, and high fever temperature/103.2 fever for 4 hours, and was recovering from body ache, headache, chills, and fatigue. This report was non-serious.
Pt. stated I felt dizzy like 30 minutes after getting vaccinated.  I have been feeling dizzy for the past 3 weeks..  I think is my blood pressure.  Vital signs taken, B/P 138/78, HR 72, RI 6.  At 8:59am she stated I feel better now.  At 9:07am pt. went home.
Information has been received from a registered nurse and a physician referring to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 20-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot# J005693, expire date 07-MAY-2015, dose, route, anatomical location were not reported) (incorrect product storage). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all the follow up has been done.
Fever started on 10/30/2018 and red dos like rash started on 10/31/2018- first on arms and legs then spread to torso.
Patient stated she felt a little light headed like she might get a migraine. She said this was not unusual. Patient refused treatment or further observation.
Bexsero 0.5 ml was ordered by provider. Pharmacy brought vaccine in clear plastic wrap labeled Bexsero 0.5 ml. Contents of packaging was menveo 0.5 ml. Due to frequent inability of vaccine scanning, vaccine was givenat 1345.  Provider made aware of situation. Pt. displayed no adverse signs or symptoms. Vitals obtained and pt. monitored. Pt. left clinic ambulatory and in no acute distress.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No known allergies. Other medication in 2weeks was reported as No. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive pcr and rapid one full week; negative, notes: three consecutive days with negative pcr tests; Negative, notes: three consecutive days with negative pcr tests; Negative, notes: three consecutive days with negative pcr tests; Positive, notes: positive pcr and rapid one full week. Therapeutic measures were taken as a result of vaccination failure, covid-19 with anti viral paxlovid started on 07Jul2022 and stopped on 12Jul2022 with lot number 1910754A.
After the injection, the baby had a fever and her body temperature reached 38. She also suffered from cold, snot fluid, cough and these symptoms lasted for nearly two weeks. On Nov 29, we found much redness on her face and after that the redness covers her whole body for 2 weeks. The baby was very fussy and kept crying day and night, sometimes she kept crying for more than one hour. Her situation is very severe and we visited the doctor on Dec 10. The redness was still on her body and she still suffered from snot fluid and cough.
Localized swollen hard red area around injection site and unconsolable crying for 24 hours, would not open eyes just cried constantly.
Developed Bells Palsy, distorted face, droopy mouth and eyelid, not able to fully close left eye and mouth not functioning correctly. Given Prednisone  and ointment and lubricant for eye  Afraid to get second shot! Need recommendation!
inconsolable crying-mom states cry different than usual started noc of vax started improving in about 24hr & gone by 36hr;no report of inc temp;
he was wheezing prior to receiving the 2nd booster shot.; This spontaneous case was reported by a patient and describes the occurrence of WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (he was wheezing prior to receiving the 2nd booster shot.). At the time of the report, WHEEZING (he was wheezing prior to receiving the 2nd booster shot.) outcome was unknown.          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-555946 (Patient Link).
Chills through the night, disoriented, fatigue, could not stand for long period of times. Took Tylenol.
Within a few days post vax, pt developed an injection site reaction characterized by a brawny induration and swelling.  Pt was treated with Augmentin and as of 11/11/1999 the symptoms were resolving.
reported fever 106 orally & gen malaise less symptomatic p/24hr;stated fever & malaise w/in 12hr of vax;next day states to ER d/t fever;