chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fell asleep and woke up at 4am sweaty with all side effects gone, general malaise continues due to lack of sleep.; general malaise continues due to lack of sleep.; fever and chills along with extreme nausea; fever and chills along with extreme nausea; fever and chills along with extreme nausea; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies to medication, food or other products. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) and sertraline hydrochloride (ZOLOFT) and birth control (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 17:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 14Apr2021, around 23:00 on the day of the second shot the patient had a fever and chills along with extreme nausea. The patient fell asleep and woke up at 04:00 on 15Apr2021 and was sweaty with all side effects gone, general malaise continued due to lack of sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever and chills along with extreme nausea was recovered on 15Apr2021 and of the events sweaty and general malaise due to lack of sleep was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
patient reports hives starting 48 hours after injection, at injection site and extending to shoulder and left breast. took zyrtec for itching.
Pt stated the back of her tongue, feels like it is swelling, but stated that her throat doesnt feel bad. denies SOB. At 1403, pt stated that she had a strange taste in her outh and her tongue feels tight against her teeth. at that time EMTs were paged.  pt talking with EMTs reguarding medical HX and allergies. at 1440 pt is drinking water 1450 pt stated that she is ready to go home and that she is feeling better.  Pt was abulatory upon leaving and walked out of the tent and drove off.
Pt had immunizations at 11:30 AM on 06/28/01, had temp of 100.8 at 4 PM acting fine. At 8 PM had a seizure lasting more than 2 min, Went to ER and temp was 103.3-did lab,bloodwork, cbc, electrolytes were normal.
Patient is a 55-year-old female presents here with right deltoid swelling and edema and tenderness which is radiating diffusely to the neck and the right chest wall following TDAP inj in the deltoid region. Patient also had systemic reaction with fever chills diarrhea and currently is having increased pain involving the right shoulder and neck and chest region. Patient had similar reaction in the past for tetanus injection. She had a laceration for which he had to take this vaccine. Advised patient to continue ibuprofen and cold copresses. Will observe the site. Does not appear to be inected at this time. TRAMADOL p.r.n. for pain along with TYLENOL ordered. The above treatment plan and goals were discussed with the patient and he clearly verbalizes understanding. Nausea, Vomiting and edema/tenderness of right deltoid radiating to neck and right chest; fever/chills.
Patient received the vaccine on the left arm. There is a single drop of blood appeared and dripped down on the arm. There is no further bleeding after given a bandage over the injection site.  The bleed was cleaned off. There was no swelling or redness at the injection site. Patient did not complain any kind of pain nor discomfort right after the vaccination, and she was instructed to sit at the pharmacy to observe any kind of allergic reaction or adverse reactions for the next 10-15mins. Next morning, patient contacted the pharmacy complaining a very sore arm, and feeling numb on the whole left arm.
Pt recvd 3 doses of Engerix-B & 6 wk following the 3rd dose the titer test results indicated no Hep B Core Antibodies;
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment with Paxlovid from 02Sep2022 to 05Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-395985.
Hives developed on left cubital area, left fore arm, left deltoid, left side of neck. Areas red/rounded approx. 1/2cm in circular formation. Beandryl and ice pack for tx ordered by Dr.
Expired Havrix administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 1st dose of Havrix. On 06-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter reported that a dose of Havrix that was expired on 16th February 2023 was inadvertently administered to the patient. The reporter did consent to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Red, itchy rash all over chest. Swelling at the injection site, lethargy, confusion, overall feeling of allergic reaction. My arm is also red, swollen, and sore at the injection site.
Within a week, I had begun to experience severe left sided pain in my face. I was treated for different causes (all wrong) when finally on Aug 2nd, I went to the ER with facial paresis (left side) and facial movement only on the right side. I was diagnosed with Bells Palsy; my left eye does not blink or close, extreme pain persists in my left ear, my mouth is sore and keeps me from swallowing, my trachea is experiencing a sore throat. When I was started on Valtrex, within 1/2 hour all of the pain ceased in these areas - it was remarkable. I was able to eat, sleep, etc. I have to treat my left eye with covering it most of the time, as it is always open. But because of receiving the Shingles vaccine one week before, it is highly suspicious that I should start with shingles of the face
Localized swelling, redness and erythema.  Patient's mom measured circumference and it is 1.5 inches larger than other arm.
This is a spontaneous report from a contactable consumer or other non-HCP. A female consumer (patient) reported for herself. A 73-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EN6200, expiration date not reported), age at the vaccination age of 73, via an unspecified route of administration, left arm, on Feb 18, 2021, 10:45, single dose, for COVID-19 immunisation. The patient has no known allergies. Concomitant medication not reported. The patient had a horrible rash all over body, privates and head on Feb 18, 2021. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The outcome of the event: not recovered. Follow-up (Jun 17, 2021): Follow-up attempts completed. No further information expected.
onset 45 mins p/vax began acting drunk, giddiness, giggly talking non-stop, easily distracted, unable to concentrate on studies; voice slightly disarthric; able to do calculations, oriented but distractable;
Flushing, Excess moisture in eyes and mouth, strong metallic taste in mouth, weakness in knees, short vision disturbance.  Symptoms subsided after an hour.  Next day fluttering in chest.  No trouble breathing
Red ring in her arm was like poison ivy; It would itch so bad it would wake her up in the middles of the night; A devil itch; Itching very badly; Had a red ring in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091621A) for COVID-19 vaccination.     The patient's past medical history included Surgery (vein surgery) on 10-Aug-2021. Concurrent medical conditions included Diabetes, Hypertension and Infarction (Multiple infarct). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), CARVEDILOL (COREG), METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), GLIMEPIRIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Red ring in her arm was like poison ivy), SLEEP DISORDER (It would itch so bad it would wake her up in the middles of the night), PRURITUS (A devil itch), VACCINATION SITE PRURITUS (Itching very badly) and VACCINATION SITE ERYTHEMA (Had a red ring in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10 days p/vax pt became febrile (105); broke out w/a rash all over body consisting of red bumps & patches of red & rough areas; pt then had a grand mal sz; evaluated in ER & checked by MD 2 days later; no treatment needed;
14 1/2cm x 12 1/2cm area-erythematic, edema, warm to touch;DPH given, ice packs, cortisone cream, children's advil;
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA252181 (same reporter). This case involves a patient (patient 2) (age and gender not reported) who received expired vaccine of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTAVIRUS VACCINE for Immunisation. On 15-Jul-2018, the patient received 0.5 ml dose of suspect PENTACEL lot C5384AA (expiry date: 30-JUN-2018) in the left leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe Chills Beginning around 4:30AM on 4/13 Extreme Fatigue throughout 4/13 with moderate fatigue on 4/14 Severe headache of 4/13, moderate on 4/14 Moderate lower back pain & neck pain on 4/13 and 4/14 Fever running between 101F and 102F on 4/13, subsided on 4/14
Fever, joint pain, chills, fatigue, migraines, all ranging from moderate to severe
pt recv vax 21MAY96 & 4JUN96 pt devel a rubella-type rash on trunk, which reporter felt was probably r/t w/rubella vax & was mildly achy;
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on the site of injection on an unspecified date with outcome of unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), on 05Apr2021 as dose 2, single (Lot number: ER8729), on 26Nov2021 as dose 3 (booster), single (Lot number: FJ1670) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Mar2020; OMEPRAZOLE, start date: Jan2015; FAMOTIDINE, start date: Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccines in this patient cannot be completely excluded.
TINGLING ON TIP OF NOSE, JAW, HANDS AND UPPER EXTREMITIES; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: acute asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the patient experienced tingling on tip of nose, jaw, hands and upper extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling on tip of nose, jaw, hands and upper extremities on JUN-2021. This report was non-serious.
Wednesday 8 March 2017 excited to work with as a volunteer, doing really good until after I had Hepatitis B shot. Within an hour I was feeling tired, nauseous, dizzy, and headache. I came home and lay down. I woke up - was worse. I started taking my migraine medications, thinking that I had a migraine  tried to sleep. (Allergies trigger migraines for me). I called an immunization clinic on Thursday and talk to them about systems. They said I just had the flu bug. I said it wasn't the flu bug, I know what that's like and this was not it. They offered nothing else, accept Tylenol, fluids, and rest. I was running a fever and I didn't break my fever till sometime on Friday morning about 3:30am.  Haven't been able to eat anything substantial. Every time after I ate - I would get a stabbing pain that in my lower right bottom rib area up sideways.  I've been able to tolerate water, Jell-O, ginger ale, and broth. Just two days ago started to eat applesauce. Today I ate some carrots. Today Monday - still fighting the headaches/ head pressures off and on.  The pain in my right side is about an inch or two below my lower rib cage to the right. At times the massive pain there was intense about an 8 - can't seem to get the pain to quit. I have been sleeping all these days only up for a couple hours and then back to sleep. Pain so bad today, Monday 13 March 2017. I'm trying to ignore it while at the HIPAA office. Came home and laid down. Pain would not quit so I called the chiropractor to look me over at 4:30. I explained the pains I was having, where they were, how I want to sleep all the time, couldn't eat without pain. He checked me out and said it was my liver. He asked what I did and I told him that I had the Hepatitis B shot on Wednesday. He said that will do it. He also said it triggered bronchitis. I came home call my sister who is a nurse. Told her what was going on, she then looked the Hepatitis B shot side effects. It states that if you are allergic to yeast - not to receive shot. I said no one asked me if I was allergic to yeast, just latex. She informed me to let you know right away. Later symptoms - I had a fever, throat hurt, stuffy nose, drank not drank not eat, sore and hurt, really weak, coughing, and chilled to the bones. My mouth was distorted just like my allergic reaction, but I didn't notice it right away because I was sleeping so much. After a week - still now feeling right - tired, weak, headache, stomach doesn't tolerate fatty foods - on a very bland diet.
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L019297, Expiry: 18-AUG-2017 and Lot# L043213, Expiry: 28-AUG-2017). The vaccines were stored at a temperature of 54 F for 10.5 hours (digital data logger). There were no previous excursions. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
With both the first and second dose I had a metallic taste in my mouth, worse the second time.  Lasted only for a short while.
I HAD LEFT ARM PAIN AT INJECTION SITE FOR TWO WEEKS (I took Tylenol) - WITHIN 24 HOURS I HAD A DELAYED SENSITIVITY REACTION SCATTERED HIVES AND ITCHING  (I am a RN and just took Benadryl 50 mg with Pepcid 40 mg po around the clock for 48 hours)
Information has been received from a healthcare worker concerning a 6 month old male who on 06-DEC-2007 was vaccinated with a dose of COMVAX (Lot # 656269/1417F).  Concomitant therapy included ALBUTEROL and BACTRIM.  On 06-DEC-2007 the patient developed a high fever for two days after receiving COMVAX (102F on the first day and 103 on the second day).  On 12-DEC-2007 the patient was examined and diagnosed with an upper respiratory infection, otitis media and wheezing.  At the time of the report the patient had not recovered.  Additional information has been requested.
This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015 RECOMBIVAX HB lot # L001456; expiration date 22-OCT-2016 and lot # L003192; expiration date 22-OCT-2016 were improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then on unspecified dates in AUGUST 2015, 3 patients received the improperly stored dose of RECOMBIVAX HB, dose and route of administration were unspecified. It was unspecified which patient received which   lot number. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
5/13/04 Client notified Immunization nurse of swelling and pain to left upper arm with fever, body aches, chills and trembling. Symptoms started 1 day after receiving vaccines.
vaccine recipient had diffuse itching and burning feeling after her vaccine.  reported she has had this with another medicine, penicillin.  continued to itch all over so administered 25 mg of Bendaryl and 20 mg of Pepcid to treat symptoms.