chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few hours after I got home from getting the shot, my lower body started to ache super bad. My skin started to hurt like I had rug burn, but I wasn't surprised because that happens to me when I get the flu. My legs and groin region started to hurt more and more and I got the chills. It was extremely bad and I was sort of writhing but I told myself I was overreacting. At around 8 or 9, I decided I would sleep it off and went to bed. At 1:00 am, I got up to use the bathroom and I began feeling lightheaded. I thought I had just stood up to fast so I continued. As I walked, i got more and more dizzy and I couldn't hear well. When I sat on the toilet, I realized I wasn't going to be able to get back up, so I sat and waited. I started to get super hot so I took my shirt off. I finally was able to get up and walked towards the sink but I collapsed before I got there. I started drinking the sink water and ran my shirt under the water and put it on my head to cool off.  This really helped so I went back to my room to call my mom. I have never fainted before or come this close to fainting. For the rest of the night I had the worst migrane of my life that gave me aura in my left eye and made my left arm and left side of my face go numb, as well as pulsing in my head. The pain on my skin, and in my legs and head was still there for two days after but it was manageable enough for me to go about my day. I tried to exercize to ease the muscle pain but this did not work.
ADMINISTERING A VACCINE AFTER 6 HOUR PUNCTURED REFRIGERATED WINDOW; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced administering a vaccine after 6 hour punctured refrigerated window. On 06-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administering a vaccine after 6 hour punctured refrigerated window and poor quality vaccine administered was not reported. This report was non-serious.
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous,  lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
Information has been received from an RN concerning a patient with asthma and no known allergies who on 06/21/1996 was vaccinated with the first dose of varicella. The RN reported that the patient received the second dose "sometime thereafter". Concomitant therapy included asthma medication as needed. The RN reported that a titer was drawn in 1999 and the "patient failed to seroconvert". Unspecified medical attention was sought. Additional information has been requested.
diffuse macular rash-arms and legs-"few days" after shots. Resolved without treatment.
Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received 0.5 ml first dose of vaccine FLUZONE QUADRIVALENT instead of 0.25ml (lot number: UJ068AB, expiry date: 30-Jun-2019) via unknown route in the left thigh on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ACTHIB for Immunisation; PNEUMOCOCCAL CONJUGATE VACCINE for Immunisation; PEDIARIX for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to overdose. It was unknown if any adverse event occurred or not following the vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
After expected days of a sore arm, I now have an itchy rash with some local swelling 5 days after shot. No open sore. It's like a huge mosquito  bite. It just started so I will have to update with more information on the resolution. I took a photo if you want it.
Information has been received from a registered nurse (R.N.), concerning a 7 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. It was reported that on an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date 30-MAY-2018 (dosage and therapy route were not provided). Concomitant therapies were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Tinnitus in my left ear.  Started a few days after receiving the 2nd shot of Moderna Vaccine.  Continues to this day
Headache, Nausea. Seen by EMS on site (Rolson 489) VS: HR 104 Regular  BP: 144/97      Spo2: 99% at 11:06 Reported improved conditions- still C/O "slight nausea " HR:98  BP:127/95    SPO2:99% 11:21 Cleared by EMS-left site Discharged home at 11:25
Patient presented to the Local Health Dept. on 10/4/18 requesting immunizations. It was discovered on our questionnaire patient had received vaccines in the last 4 weeks. She had documentation from her workplace of ZOSTAVAX and TDap given on 9/19/18. Patient had no adverse event due to vaccines given. However, patient is 21 years of age and received ZOSTAVAX which is not recommended for those under the age of 50 as best practice. It appears she was needing Varicella vaccine due to school requirements. The documentation provided by the Nursing Home facility also states it was administered IM which ZOSTAVAX is to be given SQ.
Night of vaccination and following day: nausea, migraine, fever, chills, body aches, fatigue. 12/12/21:Woke up with Hives head to toe, itching, headache and fatigue persisted
She would say like broken vessels on her underpits of her left hand, left fingers, she was sorry, so in the fingers of her left hand.; she felt her legs were swollen like inflamed; she felt her legs were swollen like inflamed; she had a little bit of blood coming out of her nose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161; Expiration Date: Jul2021) via an unspecified route of administration, administered in arm left on 21Apr2021 16:00 at single dose for COVID-19 immunisation at the age of 39-year-old. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium. The patient received the first dose of BNT162B2 on 30Mar2021 for COVID-19 immunization at the age of 39-year-old. Consumer stated, "She had the 2nd dose of the Pfizer Vaccine yesterday at 4 pm and today when she woke up she felt like she did not even know how to say, She would say like broken vessels on her underpits of her left hand, left fingers, she was sorry, so in the fingers of her left hand. It happened in her left hand. It's the 1st time she had something like this and also she felt her legs were swollen like inflamed and she had a little bit of blood coming out of her nose, it was fine when she cleaned her nose she felt little bit of blood, she had not seen of those symptoms or the side-effects of the vaccine, she did not know if it was something she should be concerned about or what?". When paraphrased the above concern, consumer stated, "She didn't see the symptoms yesterday she just realized those things this morning when she woke up like 2-3 hours ago and she was aware of them." Event onset date was 22Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Progressive weakness and areflexia improved with IVIg. EMG/NCS suggestive of AMSAN variant of GBS
24 hours later- red raised area left thigh 3 3/8" x 2 3/8" around vaccination site. Hydratisone 1 criad 25 mg, Benadryl. 47 hours later red raised red area is 4 3/4 x 7 250 mg/5ml 3 tsp Cephenxin bid for 7 days. 72 hours-difficulty swallowing aphthous ulcer increase 1 oz Lidocaine/Manlox ulcer pain.
flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
I was extremely sick; throwing up and constantly tired; I was extremely sick; throwing up and constantly tired; I was extremely sick; throwing up and constantly tired; Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) (patient).  A 80 year-old patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), VOMITING (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "I was extremely sick; throwing up and constantly tired"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea".  Additional information: When probed for name and Telephone#, consumer stated, "I really I don't want to give you my information." When probed for the concern, consumer stated, "I was like looking about side effects of (Pfizer) Covid-19 (Vaccine) two months after the last shot (second shot). I was extremely sick for about 5 days, throwing up, constantly tired and little diarrhea just Fairly Normal. I am 80 (years) old, are you finding if older people or some people having this kind of reaction? Today I feel fine, so it just lasted about 5 days, date of second shot was 18Mar2021 and date of first shot I don't know. I don't have my card right here with me." When paraphrased the concern, consumer stated, "My concern, is this normal? Has other people have faced anything two months later because after I had the first and second shot, I was fine, I didn't have any problem but 2 months later suddenly I have this reaction. I am going kind of thing, but I always wear our masks and everything." Consumer was informed about Pfizer Medical Information Department. Consumer abruptly hug up the call. Product details (LOT#, expiration date, NDC# and UOC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe Nystagmus, Blurred Vision, Dizziness.  Symptoms lasted about 10 minutes, then slowly dissipated.  Severe enough that I considered going to the hospital.  It started when I leaned forward and I felt a congested feeling in my left ear.  The other symptoms followed quickly.
cough for 30 days; This is a spontaneous report from a contactable consumer(spouse) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cough since receiving Covid 19 vaccine. The patient has had the cough for 30 days. The event resulted to a physician office visit. The patient has been to the doctor and the doctor can't figure out what's causing her cough. The outcome of the event was unknown. The reporter has questions regarding the patient's cough.   No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.
Improperly stored administered vaccine; No additional AE reported; This spontaneous report was received from other referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, administered with lot #U022727 and expiration date: 16-JAN-2023, subcutaneously for prophylaxis (dose, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius (C) up to -10 C (-11.6) for 30 minutes. It was stated that there was no previous temperature excursion. There were no adverse events reported.
Withinn 24 hours of receiving vaccination, pt started having symptoms of another shingles outbreak.  Pt called Pfizer and was told by a representative that this effect has been reported with the Pfizer vaccine.  Instructed pt to go to urgent care clinic to get started on treatment for shingles right away, since it was Saturday.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 08Nov2021 as dose number unknown, single (Lot number: 320308D) at the age of 33 years 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) all with onset 15Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient came to the ED with complaints of leg pain, cough, and chest discomfort.  Patient had tested positive for Covid earlier in the week and was treated outpatient with oral steroids and Paxlovid.  Patient was admitted to the hospital with Covid pneumonia and treated with remdesivir.
TONGUE ITCHING AT 0940; RECEIVED VACCINE AT 0721. REFERRED HER TO HER PCP.
Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm
For 2-3 days after, felt malaise, stuffy, joint pain. Starting on 3/21/21, I developed what I thought was a kidney stone with severe pain. Pain migrated on torso on left sign to lower torso. Noticed a rash developing on 3/22/21 and went into walk-in clinic 3/23/21 and was diagnosed with Shingles and prescribed an antiviral medication.
This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 5th April 2019 11:00, the patient received the 1st dose of SHINGRIX. In April 2019, 1 day 5 hrs after receiving SHINGRIX, the patient experienced stomach pain. In April 2019, the outcome of the stomach pain was recovered/resolved. It was unknown if the reporter considered the stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 6th April 2019 at 4:00 pm, the patient started to experience severe stomach pain which lasted 4 hours and resolved. On 8th April 2019 night at 9:00 pm, the same pain presented again and lasted until 5:00 am at the day reporting. The reporter consented to follow up.
Narrative: COVID infection following COVID vaccine series 02/21 Moderna ,dose #1 03/24, Moderna , dose #2 08/14 COVID swab, result: detected 08/15 pt cc: exposure; unknown
severe neurological complications ultimately rendering paralyzed from the chest down to toes,including both arms;started approx 10 days p/vax;hospitalized & tremens in hosp w/a dx condition of acute transverse myelitis
ABDOMINAL CRAMPING; EXTREME CHILLS; SHOULDER PAIN IN BOTH SHOULDERS; REALLY BAD HEADACHE; This spontaneous report received from a patient concerned a 60 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced abdominal cramping. On 02-JUN-2021, the subject experienced extreme chills. On 02-JUN-2021, the subject experienced shoulder pain in both shoulders. On 02-JUN-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramping, and had not recovered from extreme chills, really bad headache, and shoulder pain in both shoulders. This report was non-serious.
Vaccinated on 1/15.  Noting a 1inch diameter redness, firm, warm and itchy area around my injection site on 1/22 PM.  By Monday, 1/25 had a 6 inch length by 4 inch in width site, much more red and warm.  Visited my PCP, stating  a " local reaction."  No medication administered except did take Ibuprofen 200mg each day in the evening when it seemed to bother me the most.  Today is 1/28 and it is still quite evident and warm.  Used warm compresses the w/e of 1/23,24 in hope to dissipate the firm/hardness and then cool compresses since then. Afebrile
problems with his stomach; dizziness; weakness; running out of energy really fast; He is still getting high fevers; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Lot number: FA6780) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "He is still getting high fevers"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "running out of energy really fast"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "problems with his stomach". The events "dizziness", "weakness", "running out of energy really fast", "he is still getting high fevers" and "extreme fatigue" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, asthenia, pyrexia, fatigue, abdominal discomfort.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
got the first dose of the Moderna vaccine on 11Jan2021 and hasn´t received the second dose yet because the city run out of doses by the time they were supposed to get it; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (got the first dose of the Moderna vaccine on 11Jan2021 and hasn´t received the second dose yet because the city run out of doses by the time they were supposed to get it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (got the first dose of the Moderna vaccine on 11Jan2021 and hasn´t received the second dose yet because the city run out of doses by the time they were supposed to get it). At the time of the report, PRODUCT AVAILABILITY ISSUE (got the first dose of the Moderna vaccine on 11Jan2021 and hasn´t received the second dose yet because the city run out of doses by the time they were supposed to get it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Severe Atrial Fibriliation, ER visit, Treatment - 15 mg Diltiazem Bolus, 40mg IV Lasix. Outcome: Returned to normal rhythm after approx~ 12 hours
Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in an  male patient who received mRNA-1273 (MODERNA COVID-19 VACCINE,  for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Sep-2022, the patient received dose of mRNA-1273(MODERNA COVID-19 VACCINE, (ORIGINAL AND  (unknown route) .5 milliliter. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.      For mRNA-1273 (MODERNA COVID-19 VACCINE, (Unknown), the reporter did not provide any causality assessments.   The patient's age was given as approximate 70 years.  No concomitant medications was reported.  No treatment drug details was reported.