chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A Child under the age of 4 who received Quadracel with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health-care professional via consumer/non-health care professional via Medical Information (Reference number- 00780546) and transmitted to Sanofi on 21-Sep-2021.   This case involves a patient (demographics unknown) who was under the age of 4 received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "I need to find out if a child under the age of 4 who received Quadracel needs to be revaccinated due to Quadracel not being indicated under the age of 4."  No other adverse event was reported.  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 the 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.  There will be no information available on the batch number for this case.
Moderna COVID-19 Vaccine EUA. I was diagnosed Dec. 23, 2020. First injection caused medium swelling and was about an 8 on the pain scale... The next day I had a red VERY ITCHY rash about 2 inches in diameter from the site. I didn't put anything on it. Scared to. Calmed down 3days later.  Pain was better after 48ish hrs.  HURTS LIKE A BITCH!!! Thanks for all yall's hard work!
Information has been received from a health professional concerning a 32 year old female patient with no medical history or allergies who on 24-APR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 654535/0136U). There was no concomitant medication. On 24-APR-2007, the patient developed swelling in her throat and it caused her to choke. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/16/2007.  Information has been received from a health professional concerning a 32 year old female patient with no medical history or allergies who on 24-APR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 654535/0136U). There was no concomitant medication. On 24-APR-2007, the patient developed swelling in her throat and it caused her to choke.  On an unspecified date, the patient experienced shortness of breath.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered from swelling in her throat and choking.  At the time of this report, the patient's outcome of her shortness of breath was unknown.  No product quality complaint was involved.  Additional information is not expected.
Pt. had received vaccine 12/5/09 at H1N1 public clinic. He had the vaccine on 12/5/09 but did not report the rxn till 12/31/09 to the Health Dept. He stated to Dr. after the shot he had a pain in his elbow after he had already went to the Dr., he also stated he is unable to tell if it is getting better. He still is having neuropathy in the elbow. Dr. informed to keep a watchful eye on the situation and report any D's or concerns within one month. Pt. has ROM in all ext. with no problems.
This spontaneous report as received from a health professional refers to a 4 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 19-FEB-2015, the patient was vaccinated with the first dose of ROTATEQ orally, outside of the Package Insert (PI) (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effect was reported. Additional information has been requested.
Pt had requested shingrix vaccine in which came with 2 vials to be combined. Pt was given on diluent not the medication together. Pt was contacted and regiven vaccine correctly.  Advised pt to return for 2nd dose of vaccine.
No additional AE was reported; one dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from a registered nurse (RN) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported.  On 14-APR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (0.5 ml, lot # W024977, expiration date: 05-FEB-2024, therapy type: rHA) administered for prophylaxis (strength and route of administration were not provided) after a temperature excursion (product storage error). The vaccine was exposed to minus 4.9 degrees Celsius for a time frame of 1 hour 30 minutes. Previous excursion was reported as not applicable. No additional adverse event was reported (no adverse event).
Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent  (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014392: US-009507513-1612USA014393: US-009507513-1612USA014321.
pt. got very lightheaded and became limp (dropped phone) immediately after receiving vaccine.  Pt was given water and food and supported and monitored. Pt improved after 15-20 minutes but remained in store for 2 hours for monitoring.
Temperature 100.2 nausea body aches injection site pain. Started at 10:30pm Tylenol take. Fever and body aches continued until next morning (2-3-21) Tylenol taken again at 7am fever down to 99.0 body aches continue. By 11am on 2-3-21 no fever temp 98.5. Body aches and fatigue. Fat rogue continued through to now . body aches gone. Pain at site gone no Tylenol since 9pm last night on 2-3-21
Fever at night (flu vaccine administered at 9am that day). Chills, sweating.  Felt very tired.
HYPOTENSION 11/15/2021 DECLINES INFLUENZA VACCINATION  ACUTE RESPIRATORY FAILURE 12/20/2021 DECLINES INFLUENZA VACCINATION  HYPOTENSION 11/15/2021 OSTEOSARCOMA, MANDIBLE  ACUTE RESPIRATORY FAILURE 12/20/2021 OSTEOSARCOMA, MANDIBLE  HYPOTENSION 11/15/2021 HTN (HYPERTENSION)  ACUTE RESPIRATORY FAILURE 12/20/2021 HTN (HYPERTENSION)
Patient vaccinated 12/22/2020.  On 12/23/2021 patient had body aches, cough, headache, pharyngitis, and shortness of breath without hypoxia.  Outpatient infusion of bamlanivimab administered.
Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Immediately after receiving the vaccine I just had a sore shoulder that was mild. 3 months after that I went to the ER on 6/26/2021 because I began to experience shortness for breath. The doctors diagnosed me with blood clots in the lungs. I was prescribed Eliquis so I am no longer taking the Celebrex. I feel better now, but I am still under treatment. I will have another evaluation between 60 to 90 days from now. I had seen my regular doctor, heart doctor, pulmonologist, and blood doctor, and they all believe that it was unrelated to the vaccine.
At 4:00 PM, I started to have soreness in my arms and legs.  At 6:00 PM, I could barely move my arms and felt a little dizzy.  By 8:00 PM, I got a severe case of the chills, felt like I was running fever, and had a slight stomach ache.  At 9:00, I got in the bathtub and continuously ran hot water on me to get rid of the goosebumps all over me and warm up.  I started to warm up at that time.  Around 1 AM, I started to regain the use of my arms and felt like my fever had passed.  After speaking to coworkers the next day, they all said they got the chills after taking their first Typhoid vaccine.  I was shocked because chills wasn't listed as a side effect on the Vaccine Information Statement.
headachy; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were unknown.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient stated, she did not like to provide the exact date of birth due to security reasons. The day before the reporting date, the patient got the Shingrix.  She felt tired and headachy and asked about the duration that, these events could last.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "he had a cataract surgery" (unspecified if ongoing), notes: he had a cataract surgery and he's taking Latanoprost drops for his eyes for Glaucoma; "Thyroid" (unspecified if ongoing), notes: he is taking Levothyroxine for Thyroid everyday (100 mcg); "cholesterol" (unspecified if ongoing), notes: he also takes atorvastatin for his cholesterol; "MRSA" (unspecified if ongoing), notes: 4 years ago he was diagnosed with MRSA (Methicillin-resistant Staphylococcus aureus).; "arthritis" (unspecified if ongoing), notes: he has a history of arthritis. Concomitant medication(s) included: LATANOPROST taken for glaucoma; LEVOTHYROXINE taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Covid-19 vaccine (DOSE 1 MANUFACTURER UNKNOWN), when the patient was 77 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 2 MANUFACTURER UNKNOWN), when the patient was 77 years old, for Covid-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "onset of Diabetes per his doctor"; OBESITY (non-serious), outcome "unknown", described as "obese". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: On the border for onset of diabetes. Additional information: Patient wanted to know where he can receive a second booster dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there was a clinical trial where he could receive the second booster shot. Patient stated that he was trying to see if a second booster vaccine was available or if he could volunteer for the second booster and had a study done. He got the booster about 3 months or a little more ago from day of report. Patient stated that he did not have the dates or Lot Numbers of his vaccines available at the time of report. Stated that he left his vaccination card at home, he had a picture of it on his phone, but he did not know how to open the picture while he was on the phone. Patient stated that he got the first, second and booster dose. The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial dermatitis/erythema resolved but subsequently on day 5-6, has developed a localized dermatitis, erythema and edema to the muscle anterior to where the injection was given with local inflammatory response to her neck, elbow, and hands. No systemic concerns
Positive test and symptoms for Covid 19. High fever, malaise, sore throat,  cough, intestinal distress, diarrhea. 8/22/2022 2-1/2 months after 2nd booster. 1,2, 1st booster were all Pfizer-biontech.  8/23/2022 telemedicine Dr who prescribed Paxlovin. Started dosage 7:30 PM 8/23 and continued 5 days.  Felt better by 10PM 8/23 continuing for duration of prescription and following.  Symptoms remaining are slight malaise, and strange stomach flutters. Wellness sched 9/6/2022
Immediate pain in left arm. Started chills and being tired in about 3 hours. Later fever approx. 101, chills, and muscle aches all over.
Extremely sore arm about 6pm, then shakes and sweats into the night so bad my jaw was rattling. I had to bite down to stop it. Woke up sore everywhere. I had a bad headache, my face hurt, my hair hurt to brush, my jaw hurt, my eyes hurt. I was nauseous and had no appetite. This lasted 24 hours. I was dizzy when standing. I drank many glasses of water and made the decision to hold on until this passed. About this time I started to feel better, but still shaky. I ate something simple, took aspirin, took a nap. That night I had terrible night sweats. I must have sweat out all the toxins because I was better this morning (day 3). I had a very similar reaction to shot #1 of my shingles shot 2 years ago if this helps.
Patient became dizzy and nauseous lasting over 30 minutes. The patient was offered EMS help and refused.
a little bit dizzy; On his left side of his face he has a very subtle tingly feeling.; sleepy; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 17:00 (Lot number: EW0158) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to shellfish" (unspecified if ongoing), notes: Allergic to shellfish, shrimp, and lobster; "Abdominal hernia" (ongoing); "hypertension" (unspecified if ongoing), notes: The caller has had hypertension on and off, and he was almost prediabetic but isn't any longer. Family history included: "prostate cancer" (unspecified if ongoing), notes: His dad has prostate cancer; "depression" (unspecified if ongoing), notes: His family has a history of depression and things like that. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "sleepy"; FATIGUE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "tired"; DIZZINESS (non-serious) with onset 16Apr2021, outcome "not recovered", described as "a little bit dizzy"; PARAESTHESIA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "On his left side of his face he has a very subtle tingly feeling.". No follow-up attempts are possible. No further information is expected.
Patient experienced a syncope episode post vaccination. Patient laid down on the floor for about ten minutes, she drank water and was able to recover on her own.  She also stated that this happens when she doesn't have anything to eat or drink. She refused us to call 911. She then waited for about 20 minutes in the observation area and was able to leave on her own
Information has been received from a pharmacist concerning a patient who was "recently" vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 655592/1175F). Subsequently, the patient experienced redness at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
Fever of 102 F. Achy. Chills. Sore Throat. Cough.
5 hours after injection I developed chills and uncontrollable shaking that lasted for a little over 4 hours. I was feverish, nauseous and very lethargic.  The  unsettled stomach and tiredness lasted another 24 hours.
Developed a rash all over torso 10 days after vaccine. Took Benadryl for a day and rash went away after about 3 days,
Received first Covid shot, immediately had aura of a seizure, then had seizure like activity
Patient received 1dose of Pfizer and was sitting in 30 minute observation area. He presented with "throat tightness", AO x4, patient denied SOB, pain, and itchiness. Vitals taken at 6:15pm BP 134/72, HR 95, O2 97%, Temp 97.3. Patient reported history of anxiety, CHF and stroke. Patient was able to take sips of water, an EMT administered 25mg of Benadryl at 6:18pm. Patient observed for 30 minutes. Patient reported he felt better. Patient was advise he may become drowsy. Brother picked up patient.
Patient was given vaccine in right deltoid, this is his 3rd in the series of 3. After sitting for about 2 minutes I asked the patient how he felt, patient states dizzy. I then proceeded to call help and the provider PA-C and LPN came and we placed patient supine in the floor. His vitals was taken. His blood pressure was 100/54, pulse was 58, respiration was 18 and no pain.  The patient was then given some water, a cold rag and a cookie. Patient rested in the floor for about 10 minutes, then we got him to lie on the bed for another 30 minutes, patient pulse was 70 before he left. I got patient to stand about 5 minutes before he left.
abdominal cramping/pain headache stomach ache pain/soreness on arm and itching
Developed lightheartedness , abdominal cramps, nausea, hypotension.
7 year old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age/No AE; 7 year old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age/No AE; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 7 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5202AA, Expiry date- 16-May-2019 via unknown route in the right thigh on 16-Mar-2019 instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that 7-year-old female given Daptacel instead of Tdap on 16MAR2019 outside of recommend age.   No side effects reported.   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.  Documents held by sender: none.
pt recvd vax 12DEC93 & pt seroconverted for mumps & rubella; however there was a lack of response for measles; No further details were provided;
Immediately when I pulled into my home (at approximately 20 minutes post-injection), I started having a tingling sensation in my left arm.  A couple of minutes later, I had moderate abdominal pain and an immediate wave of nausea.  I also went into an immediate full-body sweat and became so hot that I was stripping clothing off as I was running to the bathroom to vomit.   I vomited many times while also having diarrhea and sweating profusely.  It came on very fast and felt very, very serious, but also subsided all at once too -  about 30 minutes later.  Emotionally it felt very disorienting and oddly scary.
Pain, swelling, redness, heat over the entire left arm from the deltoid injection site down to the elbow. Treatment: Cephalexin 500mg twice daily x 10 days.
Ever since I got my second vaccine, I have been spotting (bleeding). It's been consistent since the second dose in August and it's nearly July. I still have my period in addition to the daily spotting.
This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
One week after injection I got the "covid arm". This was extremely minor but I wanted it to be documented for scientific purposes. Injection site had previously been painful for 3 days after injection but pain had subsided. At day 7 post injection, the injection site became slightly inflamed (puffy) with minor pain that was much less severe than initial injection pain. After 24 hours these symptoms were reduced. At 48 hours symptoms were gone.
pt recvd inject & 2 wks later devel flu-like synd w/leg weakness which cont as chronic condition; CDC contacted felt poss vax caused condition; pt devel disease like MS (auto immune type) & fulminating infect & died;