chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo, can't bend/can't stand on my leg; I am getting weird; It started with really severe tinnitus which still have.; Nausea; Headache; Chills; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "It started with really severe tinnitus which still have."; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset Apr2021, outcome "not recovered", described as "Chills"; VERTIGO POSITIONAL (non-serious) with onset May2021, outcome "not recovered", described as "vertigo, can't bend/can't stand on my leg"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "not recovered", described as "I am getting weird". The events "it started with really severe tinnitus which still have.", "nausea", "headache", "chills", "vertigo, can't bend/can't stand on my leg" and "i am getting weird" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, nausea, headache, chills, vertigo positional, feeling abnormal. Additional information: Patient has not taken other products. Patient was having some really bad adverse effects from COVID shot and he just want to talk to somebody about it because the patient was struggling. Patient was about to go to the emergency room but wanted to call to Pfizer first to log his complaint. Patient had the events after five or six days after the first shot. For the last four days patient had a bad nausea, headache and chill. Patient got really really bad vertigo, can't bend, can't stand on leg. Patient thinks he is in a bad state. The tinnitus is bad and the patient can't deal with it. Patient stated that the events are probably getting worse and patient was getting weird. Patient went to his physician and game him nothing. They had nothing for the patient but was told to go to the emergency room if problem persist. Patient was prescribed nothing. Patient was about to take two paracetamol (TYLENOL) but he was scared to take anything because of his tinnitus. Patient has a lot of questions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt had passed out after 5 mins of vaccine administration. Pt came to and ambulance was called for check up
Received 3 Moderna Vaccines. 1st received on 3/31/21.  Then she received her second and third vaccine on 5/3/21 and 6/1/21.  I spoke to find out if this was an error or if she did receive 3 vaccines.  She expressed she did receive 3 doses.  She stated she did not return on the proper date after getting her first vaccine so she thought she had to start the series again.  She denied telling  that she received her first dose.  I asked her If I could have a nurse call her back to fill out the VEARS with her and she agreed.  Multiple attempts were made to contact this patient to get additional information to fill out forms.  She has not called back after several voice messages were left.  I am completing this form with only the information from my initial contact with her.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: swelling of joints-Mild
Patient received her vaccine and took a seat in the waiting area. After about 10 minutes she fainted and fell off her chair. Patient's mom yelled after it happened and the pharmacist and rushed over to help. When the pharmacist got to the patient she was face down and when they turned her over she got up. She did not appear to have hit her head and regained consciousness quickly. 911 was called at the request of patient's mother and the patient did not leave in the ambulance.
As per patient, patient arm hurt next day after  vaccine injection. She saw a doctor and upon exam the injection site was infected
Chills, Weariness and headache. After those symptoms subsided, my neck spasmed and locked up. Still a little tight a week and a half after second dose.
Fast heart rate; Increased blood pressure; Had anxiety on my skin; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. The patient had known allergies to shellfish. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On 22Mar2021 at 23:30, the patient experienced fast heart rate and increased blood pressure. It was reported that the patient felt as if she had anxiety on her skin. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The reported adverse events were treated with propranolol(UNKNOWN MANUFACTURER) 20mg as a therapeutic measure. The clinical outcome of the reported events fast heart rate, increased blood pressure and anxiety was recovering at the time of this report.    No follow-up attempts possible. No further information expected.
Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 15Apr2021 10:45 (Batch/Lot Number: EP7534) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, diabetes type 2, and known allergies to any antibiotic with sulfur. The patient was not pregnant. Concomitant medications included lisinopril, metformin hcl and ezetimibe. The patient previously took vancomycin and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 25Mar2021, 10:45. On 15Apr2021, at 21:00, the patient experienced neuropathy and had burning pain in legs. The event resulted in doctor or other healthcare professional office/clinic visit. There was no therapy for the event. The patient had no other vaccine in 4 weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Hx ESRD, CKD, DM, HTN. Presented for SOB. Required HD, intubation. Remained hypoxemic on max vent settings and ultimately coded and expired.
covid positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (covid positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (covid positive). At the time of the report, COVID-19 (covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Her second dose was due on 04/23/21. However, she was diagnosed with covid positive on 04/21/21.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-05-2021: No new information
brachial neuralgia rt arm w/neuralgic amyotrophy, weakness of arm w/limited motion of thumb & index finger; MRI nl undergoing physical therapy as of 8FEB94;
During a mass flu clinic for adults and children, a child received "FLUARIX" meant for 18 year old and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.
PATIENT DESCRIBES LUMP APPROXIMATELY THE SIZE OF QUARTER AT INJECTION SITE, REDNESS, PAIN WHICH IS BETTER WITH TYLENOL.  ADVISED PATIENT TO CALL MEDICAL PROVIDER IF NOT IMPROVED BY TOMORROW.
This is a vaccine administration error. The patient was given ProQuad (MMRV) rather than the intended MMR vaccine. This was given concurrently with other intended vaccinations today including Varicella vaccine (Varivax), Hepatitis B vaccine (Engerix B), and Tdap (Boostrix).
dizziness, lightheaded, exhaustion, coughing, fever, sweating  13hr sleep , Ibuprofen , and water
red face, puffy eyes, h/a, welts on chest more rash, stomach pain, skin hot, pt felt chilled;
Received vaccines on 9/18-06 on 9-20-06 left thigh red and swollen, fever up to 104.  Mom brought patient to emergency room.  Patient then brought into office on 9-21-06 for follow up.
Body shakes; Thirsty; Hardcore stuttering; Similar to body reaction when she had Pitocin when giving birth; Fatigue; Super sore arm / sore arm; low fever of 99 to 100; Chills ,teeth chattering she thought they would crack; Headache that felt like an aneurysm; teeth chattering she thought they would crack; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body shakes), THIRST (Thirsty), DYSPHEMIA (Hardcore stuttering), VACCINATION COMPLICATION (Similar to body reaction when she had Pitocin when giving birth) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol, FISH OIL, VITAMIN E NOS (OMEGA 3 [FISH OIL;VITAMIN E NOS]), VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], ZINC, SELENIUM and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TREMOR (Body shakes), THIRST (Thirsty), DYSPHEMIA (Hardcore stuttering), VACCINATION COMPLICATION (Similar to body reaction when she had Pitocin when giving birth), FATIGUE (Fatigue), MYALGIA (Super sore arm / sore arm), PYREXIA (low fever of 99 to 100), CHILLS (Chills ,teeth chattering she thought they would crack), HEADACHE (Headache that felt like an aneurysm) and CHILLS (teeth chattering she thought they would crack). At the time of the report, TREMOR (Body shakes), THIRST (Thirsty), DYSPHEMIA (Hardcore stuttering), VACCINATION COMPLICATION (Similar to body reaction when she had Pitocin when giving birth), FATIGUE (Fatigue), MYALGIA (Super sore arm / sore arm), PYREXIA (low fever of 99 to 100), CHILLS (Chills ,teeth chattering she thought they would crack), HEADACHE (Headache that felt like an aneurysm) and CHILLS (teeth chattering she thought they would crack) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported patient takes healthy supplement for immunity. Treatment included Tylenol liquid for symptoms. Patient had also reported having blood titers antibodies checked 3 weeks ago and it was over 10. Patient reported that 12 hours after the second dose experienced fatigue, super sore arm, low fever of 99 or 100, chills, body shakes, teeth chattering she thought they would crack, thirsty, similar to body reaction when she had Pitocin when giving birth, hardcore shuttering, headache that felt like an aneurysm.   This case was linked to MOD-2021-364732 (Patient Link).
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml (lot number, route and site not reported). After vaccination, the patient experienced shingles. This is one of several reports received from the same source. Additional information has been requested.
About 4 hours after injection, I had strong chills that lasted 1-2 hours, a strong headache, full body aching/pain particularly in low back, legs, shoulders, and a 100 F fever. All symptoms except chills lasted throughout the night until now (8:15 AM). Currently have strong lower back pain, weakness in legs, headache, and a sore injection arm.
no adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date).    No concomitant and treatment medication were reported. 14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 8DEC2022 to 10JAN2023. This case belongs to 8th adult  out of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live follow-up received include patient demographics, vaccine administration added, event onset updated. On 24-Jan-2023: Live Follow-up no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case
Fever started around 10:30 pm 3/13/21; splitting headache, nausea, 7/10 pain at site of injection; fever went as high as 102.7 on 3/14/21. Slept for 30 hours, with fever staying over 100 until the evening of 3/14/21.  Could not eat, due to nausea; got up every couple of hours to drink water and take temperature.  Awoke on Monday, 3/15/21 with no fever, no headache, no nausea, but feeling like I could still nap even after sleeping for 30 hours.
Right axillary tender/painful lymphadenopathy (same arm as injection); This is a spontaneous report from a non-contactable physician.  A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ek4176, expiry date not reported), intramuscular on 11Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The first dose of BNT162B2 (lot number eh9899) for COVID-19 immunization was administered on 21Dec2020 intramuscularly on the left arm (age 31 years old). On 12Jan2021, patient experienced right axillary tender/painful lymphadenopathy (same arm as injection) 24-72 hrs after vaccination. No treatments received in response to the events reported. Covid test post vaccination included nasal swab (BD) on 15Jan2021 with negative result. The outcome of the event "right axillary tender/painful lymphadenopathy (same arm as injection)" was recovered in Jan2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5-10 min after KINRIX, MMR, VARIVAX, pt -> cough, elevated WOB, vom x 1, redness & swelling both entire legs, wheezing -> blue lips, decreased air exchange -> epi/O2; XOPENEX/BENADRYL/SOLUMEDROL/XOPENEX again -> transport by ambulance to hosp for O2 sat 88 1 hour later still off O2 & pallor.
Pt developed rash at injection site, swelling, itching and rash is warm to touch. Rash is 4 x 2 inch in diameter. Pt also experienced palpitation 4-6 hrs. later. Pt got shot on 6/15/12.
Pain first started in lumbar muscle mostly at night accompanied by fever 1 week later, back resolved and pain moved to muscles of left (esp) and right shoulder; Myositis - presumptive with this pt.
Initial information received on 16-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a nine months old female patient and reported that the second dose was given too early of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines were given at the time of FLUZONE QUADRIVALENT. On 01-Nov-2018 at day time, the patient received a 1st dose of suspect 0.25 ml INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ005AD and expiry date: 30-Jun-2019) (route and site of administration was not reported). On 12-Nov-2018 she also received a 2nd dose of the same vaccine. It was a case of actual medication error due to drug dose administration interval too short. It was not reported if any adverse event experienced by the patient. 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. List of documents held by sender: none.
3 hours after I felt hot in the face and mild head ache started. also felt disoriented and weak.  after 2 hours I felt normal. The day after I woke up feeling very tired and weak. I called in sick and rested that day.
fever; sweats; chills; aches and pains; weak; injection site redness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J7FE, expiry date 19th June 2022) for prophylaxis.   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain, weakness and injection site erythema. On 16th November 2020, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain, weakness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever, sweats, chills, aches and pains, weak and injection site redness. The patient stated that all events resolved except for the injection site redness. The reporter did not consent to follow up. This case has been linked to US2020226619, US2020226621 cases; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226621:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020226619:SAME PATIENT (2ND DOSE)
5 minutes after injection, very nauseous and threw up 4 times, sweating, chills, difficulty breathing
Patient had flu shot on 11/28/2006. On 12/02/2006 developed intermittent tremor on left arm that became constant 12/03/2006 (same arm as vaccinated).
erythema, induration for 5 days seen in MD office 11JAN99 recovering;
legs were shaking; Needs to take baby steps, Wall support; Tripping; Fall 4-5 times; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support), DIZZINESS (Tripping) and FALL (Fall 4-5 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Insomnia, Schizophrenia and Mania.   On 02-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support), DIZZINESS (Tripping) and FALL (Fall 4-5 times). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 12 milligram once a day. On 11-Apr-2021, FALL (Fall 4-5 times) had resolved. At the time of the report, TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support) and DIZZINESS (Tripping) outcome was unknown.        Concomitant products included Unspecified Anxiolytics, Unspecified Sleep aids, Unspecified Antipsychotics.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-117963 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-117963:Friend
He experienced a change of condition on 11/12/21 with frank bleeding in catheter bag, pain in LLQ and worsening tremor.  He reported feeling achy all over and pain in left pelvic area.  The resident had a telehealth visit in the nursing home  with the PA. His blood pressure was 153/99. He pending transfer to ER when his vital signs ceased and he was unable to be resuscitated with CPR.
Around 10:00 the night after receiving the first covid injection, I got a very strong "chemical" taste in my mouth and I could also smell the "chemical" smell at the same time. It was not something I've ever smelled or tasted before. It lasted for only a second or two, then was gone. It hasn't happened again. The next day, I talked to my friend and she said the same thing happened to her, but she thought it was just her imagination. I urged her to report it to the CDC as well. I informed my doctor and she told me to report my incident to the CDC, which is what I'm doing here.