chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204, expiry date Jun2021), via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included Blood pressure high, diagnosed with COVID-19 earlier since 23Dec2020. Concomitant medications were not reported. Patient stated, "I just have a question I do not sure you could even answer, I got the first shot, I had COVID and I got like a severe reaction almost like COVID again (on 08Mar2021), I was wondering you know I have been reading maybe you do not need second vaccination if you had a strong antibody reaction." Due date of second shot was reported as 29Mar2021. Treatment for the event included taking Tylenol at 325mg. The outcome of the event was resolved in Mar2021.
Information has been received from a pharmacist referring to a 57 year old female patient with no medical history or drug reactions/allergies. On 23-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot# K020801, expire date 31-JAN-2016) subcutaneously in the left arm as routine vaccination. There was no concomitant medication. On 23-JAN-2015, after receiving ZOSTAVAX the patient experienced swelling, redness, and warmth at the injection site in her left arm. No treatment was given for these adverse events. There was no lab diagnosed studies performed. The outcome of these events was reported as recovered in January 2015. The patient did not seek medical attention. There was no product quality complaint (PQC) involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Pt reports 2 days after vaccine given, she woke up with a very sore arm - painful and numb at the same time - she had a hard time moving her left arm - she knew something was wrong. The next week she began frequent visits to the chiropractor who said there was a lot of inflammation. Pt states she is feeling better but her arm still hurts.
This is a spontaneous report from a contactable consumer (the patient). A 27-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 27, via an unspecified route of administration, left arm, on Aug 28, 2021, at 11:45, single dose, for COVID-19 immunisation. Medical history reported as none. The patient did not have any known allergies. There were no concomitant medications. The patient had swollen eyelids and red eyes about 8 hours post injection on Aug 28, 2021, at 20:15. The patient did not take other medications in two weeks. No other vaccines were taken in four weeks. No therapeutic measures taken in response to the events. The patient did not have COVID-19 prior to the vaccination. The patient did not get COVID-19 tested post vaccination. The outcome of the events: not recovered. The lot number for the vaccine (BNT162B2), not provided and will be requested during follow-up.
Guillain Barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Influenza vaccine, the patient experienced Guillain barre syndrome. The reporter stated that, it took over a year for the patient to recover. The reporter stated it was life changing. This case is 1 of 3 linked cases, reported by the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR164914:same reporter US-GLAXOSMITHKLINE-US2020AMR164910:same reporter
patient passed out. her lips turned white and once she regained consciousness she felt dizzy and nervous. while she was unconscious for the few seconds, she seemed to be having a seizure. it happened pretty quickly. paramedics was called and saw the patient. after a few minutes she felt better and was good to leave.
Patient seen at Emergency Rm on 2/25/17. Diagnosed with Cellulitis left arm/shoulder area near site where pt recvd PEDIARIX vaccine on 2/23/17. Treated with antibiotics-augmentin, recommended ibuprofen or Tylenol and ice/cold packs.  Pt's initial local reaction red bump reported 3 hours after injection.  Prt not reexamined on that date.  On 2/24/17 patient seen at Urgent Care, diagnosed with local reaction secondary to immunization and recommended ibuprofen or Tylenol and ice/cold pack.
At 1:15 PM, on Tuesday, November 19, 2019, I got the flu shot for this year, ("AFLURIA QIV PFS 2019-2020 INJ  0.5 ML", Quantity: 0.5).  I felt totally fine when I got the shot.  At about 7:15 PM, I started feeling nauseated (never actually vomited); I got chills, and I was shaking.  Also, my eyes were excreting a lot of gunk.  I felt like I had a fever, but we checked, and I did not.  Also, all the color in my face was drained - I was a pasty white.  I laid down on the couch with extra covers and the shaking subsided, and I sipped water.  We considered going into Urgent Care, but by 9:15 PM, I was feeling quite a bit better, and the color started returning to my face.  By the next morning, I was feeling fine.  I am a 64-year-old woman in good health, and I exercise regularly.  I have not had a negative reaction to any previous flu shots.  The reason I'm submitting this is that my reaction to this year's flu shot doesn't seem to be described in the pamphlet covering the possible reactions to the flu shot; and therefore, I thought I should let you know.  Thank you for your concern.
Lip Tingling and Minor Swelling started approximately  5 min after shot Tongue Tingling and Minor Swelling started approximately 5 min after shot Blood Pressure increase to over 200/100 - taken approx 10 min after shot and then 15 min after shot, at approx 25 min after shot was down to approximately 160/90
Received 5 immunizations late morning of 10/19/04 at the Health Department. Mother stated that child developed fever but she did not measure. Mother brought to hospital ER on 10/20/04 at 10pm after a febrile seizure which occurred earlier in the evening. Temperature of 105.2 degrees rectally recorded in ER. Mother stated that 13 mo. old male awoke crying.  He then stopped crying and began shaking all 4 extremities-an activity noted for approximately 3-5 minutes.  The infant was not responsive at this time.  When he stopped convulsing, he became limp.  His parents stated that the child was not responsive to them for approximately 10 minutes after which time he returned to his normal mental status.   Parents did not report any additional symptoms other than the fever.  On 10/17/04, infant seen in the ER, dianosed with an ear infection and sent home on Amoxil.  13 mo. old drinking fluids well with a wet diaper in the last 2 hours.  History consistent with a simple febrile seizure.  Past medical history significant for pneumonia and tuberculosis exposure.
A few hrs after vaccine got arm redness and warmth and swelling and fever. 5 days later seen at urgent care dx cellulitis.
Patient weakness unable to diagnosis specific cause. Onsite EMS was called vitals BP 110/60 99% O2 HR 86. Patient refused evaluation or care without transport, released agianst medical adivse.
hives- 1 hour after vaccine Tx: Zyrtec (self treated) Received dose 2 1/11/21
Disseminated Granuloma annular; My entire body was covered by the lesions; Leaving my skin damaged in many places; became allergic to many food and preservatives; became allergic to many food and preservatives; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from the Pfizer-sponsored program. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (Manufacturer: Pfizer, lot number and expiration date unknown), and influenza vaccine (FLU VACCINE VII) both via unspecified routes of administration on an unspecified date in 2015 (reported as 6 years ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. 6 years ago, after simultaneously receiving a Flu vaccine and a Pneumonia vaccine administered by a local pharmacy, the patient developed Disseminated Granuloma annular. It took almost 9 months, until the lesions fully came out. The patient's entire body was covered by the lesions, but her face. It took almost 1 year for the lesions to fade, leaving her skin damaged in many places. She became allergic to many foods, as well as preservatives in foods and drugs. The patient is 73-years-old and was asking if the COVID Vaccine is for her. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
After vaccine administration, mom stayed in exam room to nurse the infant.  While nursing she noticed he was shaking.  She layed him on the exam table where she saw his arms shaking and he "was not acting right".  She called the nurse who notified me.  At my exam he was hypotonic and hyporesponsive.  Pulse ox. 96%, HR 130's, RR 14.  HHE lasted approximately 5 minutes after which he was smiling, cooing, and behaving normally.
Extreme exhaustion since the second dose vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 21Feb2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021, since the second dose vaccine, the patient experienced extreme exhaustion. The patient did not know if this was related to the second dose of the vaccine but reported that it had occurred since that time. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme exhaustion was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient described "started to not feeling well by 6:00pm that night, body aches, muscle and joint ache, headache, started running fever, chills, 101. On Friday, diarrhea. symptoms receded by Saturday PM.
Two days after the vaccine I woke up achy and with a slight fever. Not long after I woke up I began having trouble thinking through sentences and had some trouble speaking. I goto up to get some water and was dizzy. I walked into the wall repeatedly. During the rest of the day I couldn't remember anything from one minute to the next. Cognitively I couldn't put things together. It was terrifying,like being in a box and not. being able to get out.  This lasted for about 24 hours.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (route of administration not reported) lot # L011537, expiration date 03-JUL-2015, that was improperly stored. There was no adverse effect reported. Additional information has been requested.
Fever 100.2, chills, aches, extremely swollen injection site, swollen and very painful lymph nodes in armpit and breast area, pain in all joints.
Headache, muscle aches, nausea, fatigue, pain and redness at injection site, chills. Most were gone by noon on 9/15, headache persisted all day 9/15, pain and redness still there on 9/16.
The patient came in to our ED department for a complaint other than Covid. While the patient was her the provider ordered a Covid vaccine to be given before he left. It was found after the patient was discharged that the wrong diluent was used to reconstitute the pfizer vaccine. Sterile water was used instead of the recommended Normal Saline. Pfizer and the CDC was contacted. Due to the lack of data the CDC recommended that we revaccinate in the opposite arm. The patient has been initially contacted via voicemail and we are waiting a response. We will continue to contact the patient until we have a conversation with him if possible.
MISHANDLED JANSSEN COVID-19 ADMINISTERED TO A CONSUMER; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced mishandled janssen covid-19 administered to a consumer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mishandled janssen covid-19 administered to a consumer was not reported. This report was non-serious.
Information has been received from a registered nurse concerning an 81 year old female patient already deaf in left ear with hypertension, diabetes, peripheral vascular disease, renal insufficiency, artherosclerosis, coronary artery disease, VOLTAREN allergy, red dye allergy and sotalol allergy and a history of dialysis who on 28-JUL-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (Lot # 664320/0560Y). Concomitant therapy included NEXIUM, SYNTHROID, LASIX, LANTUS, HUMULIN, LIPITOR, COUMADIN, METROGEL, magnesium unspecified), digoxin, ZAROXOLYN and COREG. On 08-AUG-2009 the patient developed pain in her right ear and then became completely deaf in her right ear. The patient went to the office and was given ROCEPHIN. The patient was currently taking KEFLEX and VERAMYST. The patient had a hearing test performed (results not provided) and a procedure called "ear popper" was also done in the office. At the time of this report, the patient had not recovered. Developed pain in her right ear and became completely deaf in her right ear were considered to be disabling. Additional information has been requested.
On 12/12/22 I started feeling sick I had a sore throat, lingering cough,fatigue, nose congestion,chest congestion and a low grade fever of 101.0  On 12/14 I tested positive and had a telehealth appointment on the same day. I was prescribed a 5 day course of Paxlovid which I completed. I am feeling much better at this time.
Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative: Employee got the first dose vaccine 12/22/2020,at 11:03. She stated  that she had worsening nausea, vomiting and diarrhea addition to easy fatigability  on 01/11/2020. She has covid test done 01/19/2021 which was negative. She did  not seek medical advice. She stated that she stayed home and had Zofran as needed for 2 weeks. Employee has h/o hypothyroidism, migraine headache and  hypertension
Child had no reported adverse event; varicella vaccine had been in refrigerator for 75 hours; per Merck [manufacturer], because of the lot, this was too long a period out of freezer to be certain vaccine was still full potency.
Next day after the vaccine dose administration she begans with itching and skin rash in the left arm. Urticaria all over the body with persistent  skin rash. She went to the primary physician office to be evaluated on october 11, 2018.
very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003D21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SOMATROPIN, DICYCLOMINE [DICYCLOVERINE], LISINOPRIL and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-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 PYREXIA (very high fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (very high fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 to 101.6 (High) 101.3 F to 101.6 F.         Action taken with mRNA-1273 in response to the event was not applicable.
a 6 month old patient received the DTAP-IPV portion only from the Pentacel; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old patient who was vaccinated with 0.5 ml only DTAP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]( batch number: UI966AAA, expiry date: 07-July-2020) via unknown route in right thigh, on 18-Jan-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE (HEPATITIS B VACCINE); and ROTAVIRUS VACaCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (02Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Product was COVID 19 treatment, brand was Paxlovid and treatment start date at 26Jan2023, treatment stop date at 31Jan2023, Indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Unbelievable STABBING PAINS IN MY EARS. BOTH MY EXTREMITIES ICE COLD NOT, like chills. SO COLD ALL MY FINGERS TURNED WHITE. EVEN running them under warm water did not HELP. Full body joint PAINS. HEADACHE, & EXTREME FATIGUE. My right hand middle finger was so arthritic, it got stuck straight up. I could not bend it. Hard to walk on my feet due to ankle pain. Again overall arthritic pain  It is Sunday. Still in bed, trying to just wait it out.  I switched to Pfizer from Moderna. The intensity of Moderna was even worse.
Fever 101.1, chills, lymph node under left arm swollen and very painful, neck aches,bilateral shoulders ache,upper back aches,bilateral wrist aches,nauseous,extreme fatigue, chest pain anxiety short of breath
I woke up Sunday morning with a very bad sore throat I wonder if it was sinus drainage or something, the next day I woke up and I had flu symptoms very congested and felt miserable. I tested the first day and the COVID-19 test was very light and the next day I tested again 16JAN2023 and the test was clearly positive.
This is a spontaneous report from a non-contactable physician. A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, it was stated that the patient covid. He had the Delta variant and was very sick. The patient also had a very high fever and had to receive anti-viral. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected. The efficacy of a drug varies from patient to patient and can be affected by different factors, however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective. COVID-19 cannot be ruled out.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 prophylaxis. No medical history was provided by the reporter.  Concomitant products included CYANOCOBALAMIN (B 12) for an unknown indication. On 14-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved. Concomitant medication were includes men's Vitamin. No treatment medication were provided. This case was linked to MOD-2022-609216, MOD-2022-609018 (Patient Link).