chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild soreness in arm; trouble holding the tab of her jeans/ felt different while doing normal stuff/ hard for her to do detailed work like touching the button of the iPad or scratching her ear; had jerking movements rather than smooth movements/fine motor movements are different; stiffness in her hands, motion not fluid; lot of weight due; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 56, no unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 04Feb2021, she's scheduled to receive the second dose on Thursday. After she received the vaccine, she experienced mild soreness in her arm, not severe for a maximum of 48 hours. When she went for a long walk (1 hour), it was a very windy day and she didn't wear gloves, when she went back she had trouble holding the tab of her jeans, she lost strength in her left hand after she washed her hands with warm water everything was fine. A week later she felt different while doing normal stuff like washing rice because she rubs the rice in the palm of her hand, and it's in both hands now. It's hard for her to do detailed work like touching the button of the iPad or scratching her ear because she has to think about it be aware of the action and it feels weird, she's most better now but this sensation occasionally comes (She did not have any tingling. At times, some movements were jerky rather than smooth, stiffness in her hands, motion not fluid). Her fine monitor movements are different. She lost a lot of weight due to other reasons, so she's not sure if this was related to the weight loss that her extremities get cold. She would like to know if it's recommended or not that she received the second dose of the vaccine. The patient heard that there have been report of Bell's Palsy and the vaccine. She would like to know if Bell's Palsy is a neurological problem related to the vaccine. She was scheduled to get the second dose the next day from the time of report. The symptoms have decreased. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Patient broke out in a rash she described as hives. She states they were covering the left arm.
expired dose of PENTACEL was administered with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HEP A IN VAC) for Immunisation; and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (MEASLES, MUMPS AND RUBELLA) for Immunisation.  On 24-May-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  (formulation, strength: unknown) lot UJ424AA, expiration date: 21-May-2022, via intramuscular route in unknown administration site as prophylactic vaccination.  On 24-MAY-2022 the patient was administered expired dose of pentacel with no reported adverse event (expired product administered) same day following the administration of suspect vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of PENTACEL was administered with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
she tested positive COVID-19; she tested positive COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced tested positive covid-19 on 12Jan2021. The patient underwent lab tests and procedures which included COVID test: unknow results on 10Jan2021, tested positive on 12Jan2021. Caller had a COVID test on Sunday morning and got the first dose of the vaccine on the same day. She received the results of the test today which turned out positive and wanted to know if she needs to repeat the first dose. Caller wanted to know if her testing positive was due to the efficacy of the vaccine or did she do something wrong or what. Caller verifies there are no other numbers besides EL1283 on her vaccine record card. The outcome of event was unknown.
Case number PHEH2014US024954, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 46-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
right arm was hurting; no rash but it's red; muscle pain; right arm was hurting so bad she couldn't move it; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had received first dose at around 4:45pm on Saturday afternoon of the Pfizer vaccine. It didn't hurt. She didn't feel a thing by 10pm that night on an unspecified date her right arm was hurting so bad she couldn't move it, it has gone back from hurting to not, no rash but it was red. The left arm was fine, hurts a tiny bit today, but it was the right arm that hurts, and it didn't make sense. It was baffling. She did not know. This arm (right) did hurt prior to but that a year ago in march (she fell and hurt her arm a year ago). It was very nice. It was nice. she felt the prick and it was wonderful. She knew it was muscle pain because she noticed it when she was driving, it hurts but then goes away instantly. Sometimes it was really red and sometimes there was not on her arm. It looked more like a burn, like a heat burn (which was not what she did). It was about 3 inches long and a couple of inches wide. No rash, the skin was smooth. She would go on the 20th for her 2nd shot. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness around the injection site; Itching around the injection site; Feels like someone punched her; It looks like it does when someone takes a bandaid off their skin; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   Concurrent medical conditions included latex allergy.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 9th October 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site erythema, injection site itching, injection site pain and injection site discoloration. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site pain and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site pain and injection site discoloration to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Within 30 minutes after vaccination with dose of Shingrix, the patient experienced redness and itching around injection site. The nurse reported that, it was barely red and dfid not worsen.It looks like it did when someone takes a bandaid off their skin. It was not swollen. the  patient stated that every time got vaccine and experienced red and itch and feels like someone punched. The reporter consented to follow up. This case was 1 of 4 linked cases reported by same reporter.
Developed hives- itching raised red rash all over the biceps and triceps of the arm, w/ vomiting and Temp of 102 w/ chills. Took Benadryl po.  Called her pcp 5/5 and was given phenergan. Sx began w/in 6 hours of the injection. The rash and fever resolved by 5/5 am. The nausea continued into the night of 5/6.
Narrative:  39 yo female with PMH GERD, depression, anxiety, migraine and PTSD was observed to have an anaphylactic reaction after her second dose of COVID19 Pfizer vaccine on 4/13/2021. Patient was sent to the ED 30 minutes after receiving the second dose of the vaccine. Pt denied SOB but had throat tightness and difficulty swallowing. Pt denied SOB, lip swelling or tongue swelling. Pt had a similar reaction with the first COVID-1 vaccine on 2/22/2021 and was treated with epinephrine. According to COVID-19 vaccine notes, patient was treated with epi 0.3mg, decadron 10 mg IV, Benadryl 50mg IV, famotidine 20mg PO with resolution of all symptoms prior to leaving ED. Patient was instructed not to receive COVID19-vaccine in the future. Per progress notes, patient was seen in same day asking whether or not she should have received the second dose of COVID19. Provider stated that patient left before he could make the recommendation that she shouldn't get it again.
Myalgia, NauseaVomiting, extreme fatigue, arm pain , chills, improved on day 2 Narrative:
Symptoms -chest pain (it feels like something sharp is stabbing me from the inside but also as though there is a heavyweight placed on my chest; my entire chest but focused mostly on the center of my chest and sometimes on the left or throughout my entire chest; pain does not go away) -throbbing headaches (usually on the top of my head or like everywhere), sometimes feels like my brain is loose and bouncing or as though it's a bomb about to explode -abdominal pain (sharp and sometimes throbbing pain; usually only on the upper left side, sometimes also on the right side as well) -back pain (aching) -joint pain and inflammation (usually ankles, knees, and fingers) -overall full-body pain (aching) -left arm feeling heavy and painful sometimes -random aching jaw pain -random shortness of breath and difficulty breathing -rapid heartbeat/palpitations (sinus tachycardia) -random fluttering in the chest and abdomen & sometimes feels like my heart is dropping -chronic fatigue & weakness -dizziness/lightheadedness -nausea & loss of appetite -blurred vision -sensitivity to light and loud noise -trouble processing what is happening, focusing (easily distracted), and brain fog -cramping, numbness, and tingling of hands & feet (sometimes shaky) -insomnia and sometimes night sweats -random hot flashes and cold sweats -collapsing -nearly fainting & fainting (about 30 seconds to 10-15 minutes, depends)  Diagnosis -mitral valve prolapse -hyperprolactinemia -nonepileptic seizures/syncope, unspecified type -sinus tachycardia  -polyarthralgia -conversion disorder -temporomandibular joint disorder -sicca, unspecified type (HCC) -mild concussion from fainting (July 2019) - cleared  Medicine -Metoprolol Tartrate (12.5mg twice a day, more as needed) -vestibular rehabilitation (August 2019-present)
Fever of 102 deg, rash around abdominal area, diarrhea.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392935 (Patient Link).
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FD0809) at the age of 76 years as dose 3 (booster), single, administration date 31Mar2021 (Lot number: EW0150) as dose 2, single and administration date 10Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; NORVASC taken for blood pressure measurement. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She reports last night but states she hasn't had any problems from her previous doses. Caller states she never had these side effects before except a sore arm that she has had before. Patient details: Caller states she thinks that she has shrunk. Caller states weight is unknown, but she is not big and fat. She states she tells the doctor she does not want to be weighed as she is not fooling with that. She states maybe 170 pounds. Caller states she has shrunk over the years and clarifies many years. Caller states the phone broke up. Caller confirms the call is about the COVID-19 vaccine. She states her vaccination card is in her purse. Caller reports the pharmacy gave her some paperwork yesterday maybe her vaccination information will be there. She states the pharmacy gave her a lot of papers. Caller reports all her COVID-19 vaccinations were Pfizer. Caller reports the date is hard to read due to the writing on her card but confirms the date is 31Mar2021. Caller states the date does not sound right. Caller asks does that sound right. Caller states the vaccination took like 3 seconds in her left arm. Indication: Caller states she saw on TV that if greater than 5 months since her last vaccination and if she is immune compromised, she should get a booster dose of the COVID-19 vaccine. She states she does not know if she is immune compromised, but she is old. She reports her granddaughter comes to her house and her granddaughter is not vaccinated. Caller states all her test results came back fine but she needs her physical this month. She reports that she hasn't had her physical since last year, but all her tests were fine last year. Caller declined to complete supplemental form as she states she has someone calling on the other line. No further details to provide.  Follow-up attempts are completed. No further information is expected.
Slight cough; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion). At the time of the report, COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Dtap #4 dose administered to left thigh. Patient complaints of swollen, redness, warm to area starting on late morning patient doesn't complain of pain, active and playful per Mom
The pain continued to get worse and spread to the point where my neck was very painful; pain on the side of my spine on the same side as the injection; pain grew much worse and spread to the other side of my spine; where my neck was very painful neck pain ,difficult to move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 14:30 (Lot number: En6203) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pernicious anaemia" (unspecified if ongoing); "iron deficiency anaemia" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: NECK PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "The pain continued to get worse and spread to the point where my neck was very painful"; SPINAL PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "pain on the side of my spine on the same side as the injection"; PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "pain grew much worse and spread to the other side of my spine"; MOBILITY DECREASED (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "where my neck was very painful neck pain ,difficult to move". Therapeutic measures were not taken as a result of neck pain, spinal pain, pain, mobility decreased.  Additional information: It was reported that, the morning after the vaccine she work up with neck and pain on the side of her spine on the same side as the injection. Over the course of the morning this pain grew much worse and spread to the other side of her spine. The pain continued to get worse and spread to the point where her neck was very painful and difficult to move. This gradually got better over the week but she continued to have mild soreness after. Patient took vaccine at public health clinic/veterans administration facility. Patient took Ibuprofen after the vaccine. Patient had no known allergies. Patient had no other vaccine in four weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
slight discomfort at injection site; feeling of fatigue, not severe but noticeable; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: WN5318, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 29Jan2021 at 11:45 (age at vaccination was 31 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included peanut allergy. Concomitant medications the patient received within 2 weeks of vaccination included cyanocobalamin (VITAMIN B12) (50 ug vitamin B12/day) and colecalciferol (VITAMIN D) (1000 IU vitamin D/day). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) which caused drug allergy. On 29Jan2021 at 12:00 pm, the patient experienced slight discomfort at injection site, feeling of fatigue, not severe but noticeable. The patient responded "not recovered" but kept in mind that a very short time had elapsed between the adverse event and reporting. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The events were reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, NauseaVomiting back pain, Narrative:
Narrative:  77 yr old male with CLL diagnosed in 2009 (del13q14). PMH significant for Hyperlipidemia, HTN, peptic ulcer disease, COPD, and asthma. Patient reported of increased fatigue and worsening adenopathy in 08/2020. Imaging CT C/A/P 09/2020 confirmed progressive adenopathy and patient was started on ibrutinib therapy 09/18/2020. Patient was tolerating therapy well and CBC normalized indicating response to ibrutinib. Patient presented to ED 4/8/21 and subsequently admitted for SOB and fatigue for 2-3 weeks since receiving the Moderna COVID-12 vaccine 3/17/21. EKG confirmed atrial fibrillation with rapid ventricular response, treated with diltiazem and heparin drip. Upon reevaluation, heart rate was controlled and SOB resolved, patient was discharged 4/12/21 with oral diltiazem and apixaban. Ibrutinib has been on hold since 4/8/21, with lab monitoring for CLL since CBC continues to be normal and stable. Ibrutinib causes A-fib (8%). Stressors, such as illness/immunizations, may trigger atrial fibrillation and 19-21% of active COVID-19 cases developed A-fib. Incidence with Moderna vaccine has not been defined.
Immediately after receipt of anthrax vaccine she experienced burning at the injection site, tingling in hands bilaterally, sweating, heart racing, nausea, and dizziness.  Nurse's note indicates BP 84/48 and P 52 supine.  No loss of consciousness.  She was sent to the Clinic when she had not significantly improved an hour later.  EKG showed S-T changes in leads V1  V4.  She was referred for a stress test.  The Exercise Stress Test was equivocal.  She had downsloping of S-T segments in leads V5 and V6 which rapidly returned to normal in recovery. A nuclear stress test was recommended.  She developed bilateral knee pain that she attributed to extra physical training.  The knee pain is effectively relieved with Naprosyn.  She is currently undergoing a taper of the Naprosyn.  She has had a subsequent dose of Hepatitis B without any adverse event.