chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a large red and swollen area on the injected arm but not at the injection site; developed a large red and swollen area on the injected arm but not at the injection site; not bend both thumbs for over 24 hours; lost at least 80 percent of my hearing in the right ear/significant hearing loss; tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-years-old female (not pregnant) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0171, Pfizer NTEC), via an unspecified route of administration in left arm on 29Apr2021 at 08:00 as a single dose for COVID-19 immunization (at the age of 62-years-old). The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that after dose two on 29Apr2021, she could not bend both thumbs for over 24 hours. She also developed a large red and swollen area on the injected arm but not at the injection site. This condition lasted 3 days. She then lost at least 80 percent of my hearing in the right ear, the patient developed joint stiffness. As of 23Jun2021 she still had tinnitus in the right ear and still have a significant hearing loss. There has not been much improvement to either symptom since 29Apr2021. The patient did not receive any treatment. The clinical outcome for the events, lost at least 80 percent of my hearing in the right ear and tinnitus was not recovered whereas for events, not bend both thumbs for over 24 hours was recovered on 30Apr2021 and for event, developed a large red and swollen area on the injected arm but not at the injection site was recovered in May2021.  Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event: deafness and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
At 11:30 pm, I experienced body aches ( neck, back, legs, and head) and insomnia.  3:00 am I took Advil.  Woke up a bit better. Just headache remained.  Totally exhausted though. Took 2 naps.  Went to sleep at 9:30 pm-6:00, second night.  Today, day 3, so far so good
About 7AM noted left deltoid area erythema/swollen when child complained of pain. States has doubled in size since first seen. Area on arm was very firm. 18 cm from top of shoulder and arm and 15 cm around deltoid.
On Friday, November 12, 2021 client came to  vaccination POD for a Covid-19 Moderna booster dose. Client received her first and second dose of Sinovac vaccine in April 2021 in Mexico. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history. Sinovac is an agency approved vaccine. Submitted medical consult via text to agency Operations Lead who consulted with Dr. Dr approved for client to receive Moderna booster dose with 30 minute observation. Client received her Covid-19 Moderna vaccine (LOT #: 066F21A) at approximately 1:54 PM in her right arm. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 2:30 PM.
sore arm; redness at the injection site; Itchy at the injection site; Hot to the touch at the injection site; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, redness at the injection site, itchy at the injection site, hot to the touch at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm, redness at the injection site, Itchy at the injection site, Hot to the touch at the injection site.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, redness at the injection site, itchy at the injection site, hot to the touch at the injection site was unknown.
PATIENT HAD AN AVERSION TO INJECTIONS AND PASSED OUT UPON INJECTION. PATIENT RECEIVED INJECTION FOR INFLUENZA, HOWEVER PASSED OUT APPROXIMATELY HALFWAY THROUGH ADMINISTRATION OF INJECTION. IMMUNIZATION WAS COMPLETED AS PATIENT BEGAN TO SLUMP OVER AND PASS OUT. PARAMEDICS WERE CALLED AND ADMINISTERED TREATMENT.  ADVERSE REACTION WAS NOT DUE TO INJECTION, BUT TO AVERSION TO NEEDLES/INJECTIONS.
Glucose 2hr Post: 47; I haven''t  been sleeping since I received the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 14:45 (Lot number: EN6205) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitamin defficiency" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for hypovitaminosis, start date: 22Jul2021 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 28Oct2019 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: 04May2020 (ongoing). Vaccination history included: Bnt162b2 (Time (24hr): 11:30 AM, Anatomical Site of injection: Left Arm, Batch/Lot number: EN6198), administration date: 11Mar2021, when the patient was 46 years old, for covid-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "I haven''t been sleeping since I received the Pfizer shot"; BLOOD GLUCOSE ABNORMAL (non-serious) with onset 11Apr2021, outcome "unknown", described as "Glucose 2hr Post: 47". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia.  Additional information: Patient had not been sleeping. She was not getting treated, she was told to take somethings from over the counter.  No follow-up attempts are possible. No further information is expected.
24hrs s/p vax 1/23/22-chills fever 101, body aches fatigue joint pain lasting 12hrs.  48hrs later, 1/24/22 left chest pain radiating to left back, left chest pressure tingling numbness traveling left axillary to left back. Bp 180/100 HR 100
Patient states that on day two after he receives the flu vaccine it is harder for him to breath and does not feel well.  He stated that the feeling of harder to breathe feeling goes away on day three.  He mentioned this happened last time he got a flu shot. He stated he has not felt very well since the flu shot which was administered 8 days ago but it is getting better.  He also has right lower flank pain that developed day 7 which is moving down his leg.  Advised  to see a doctor if the lower back pain worsens.
02/16/2021 I was dizzy, took me 40 minutes, managed to walk with escort and driver, felt unsteady. At home about 4 hours later, we went a couple blocks away and I was very disoriented, I quickly was unable to move, nauseous, no appetite, seven days spent on couch. The wrist injury from falling, was worsened from slipping on ice from disorientation.
I have never had a reaction to any vaccines. I was out that night after the vaccine and I was starting to feel SO cold, I get into bed and I turned on my heating blanket and I was convulsively shivering/shaking and I had chills and I could not get warm at all for about 1-1.5 hours. I try to get up around 2 am to use the bathroom, I am sitting on the edge of my bed and felt like I would pass out. I was so dizzy I couldn't stand up. I finally pushed myself up and held myself up on the wall and I was very nauseated and felt like passing out. I am sitting on the toilet and I am there for 30 minutes or so and thinking I need to call someone. I tried to get up but ended up having to crawl back to my bed. I was scared to fall asleep. I layed in bed and finally slept. When I woke up, I felt really drugged but the feeling of passing out was gone. I felt like I had taken a sleeping pill or something. After that I had extreme fatigue and my husband even said I looked "stoned".  I am doing fine now.
This spontaneous report as received from a medical assistant refers to a seven unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Prolonged lethargy, high fever, constipation, diarhea, developmental delay, speech delay, fine and gross motor skill deficit, cognitive deficit
Information has been received from a medical assistant referring to a 13 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012776: US-009507513-1709USA012777.
Fever this am 101F. Reaction site redness. Borders drawn site 5" x 3 3/4" redness swelling body aches, nausea.
Dizziness, nausea, chills started within 1 hour of vaccine.  Dizziness and chills subsided after 3 hours, nausea persisted for approximately 24 hours.
After receiving the injection the patient fainted. Patient was offered juice and after taking a sip she had a small amount of emesis.  A cold towel was placed on patient's forehead and then observed by EMS.
pt was given a vaccine on 11/6/21 that expired on 11/5/2021
fever that won't stop; shivering that won't stop; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2021 13:00, the patient received the 2nd dose of Shingrix. On 30th December 2021, less than a day after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix shot at 1 pm on the day of reporting and experienced fever and shivering which was not stopped until the time of reporting.
This case was reported by a consumer and described the occurrence of incorrect storage of drug in a unk patient who received ENGERIX B. Co-suspect products included FLUARIX. On 23 September 2014, the patient received ENGERIX B and FLUARIX. On an unknown date, an unknown time after receiving ENGERIX B and FLUARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to ENGERIX B and FLUARIX. Additional details: Apparently the event occurred at an offsite vaccination clinic, no vaccine or patient details were available currently.
Intermittent Temperature  Lightheaded/brain fog Extreme extreme fatigue/exhaustion  Queasy  Shortness of breath- intermittent  Joint pain Dry mouth Since 3/26/21 There is no treatment
On 6/9/21 Pt started having tingling in his feet, on 6/10/21 the tingling continued to worsen and he went to ER  were he was diagnosis with high blood pressure and sent home. On 6/11/21 pt. fell in his bedroom and the tingling had moved up his legs and he could not feel his feet. He went back to ER were he was admitted for high blood pressure and discharged on 6/12/21 to follow up with a cardiologist. Pt was taken to a different Hospital on 6/12/21 after discharge from pervious hospital because he was unable to stand or walk. Pt admitted,  pt then continued to complete the following tests; Spinal Tap,  Nerve Conduction Study, Electromyography, and full lab panels.  On 6/17/21 pt was unable to swallow and was choking on saliva. He was intubated on 6/17/21 and moved to ICU. On 6/18/21 pt had one of his lungs collapse. pt had a feeding tube and trach placed.  The week of 7/8/21 pt was moved to PPCU . Pt went to rehab on 7/29/21. Pt is still not able to move from his neck down and is 100% dependent on other for full care.
Got home Felt nauseous.  Went into the bathroom and passed out and fainted and hit her head as she passed out
looked like an infection; itchy; warm and hot to the touch; bump/red bumpy circle; it hurt all the way to the armpit/the whole shoulder and armpit area hurt quite significantly; red patch/path started growing on vaccine site; pain spread to the lymph nodes in my armpit; whole shoulder hurt quite significantly; It was sore; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (looked like an infection), PRURITUS (itchy), VACCINATION SITE WARMTH (warm and hot to the touch), VACCINATION SITE MASS (bump/red bumpy circle) and AXILLARY PAIN (it hurt all the way to the armpit/the whole shoulder and armpit area hurt quite significantly) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (The patient got Pfizer first shot on 05-APR-2021, Lot no: ER8737.) on 05-Apr-2021, PFIZER VACCINE (The patient got Pfizer second shot on 07-MAY-2021 and Lot no: EW0173.) on 07-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER VACCINE and Pfizer vaccine. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LEVOTHYROXINE for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (body aches). On 08-Dec-2021, the patient experienced INFECTION (looked like an infection), PRURITUS (itchy), VACCINATION SITE WARMTH (warm and hot to the touch), VACCINATION SITE MASS (bump/red bumpy circle), AXILLARY PAIN (it hurt all the way to the armpit/the whole shoulder and armpit area hurt quite significantly), VACCINATION SITE ERYTHEMA (red patch/path started growing on vaccine site), LYMPH NODE PAIN (pain spread to the lymph nodes in my armpit), ARTHRALGIA (whole shoulder hurt quite significantly) and VACCINATION SITE PAIN (It was sore). At the time of the report, INFECTION (looked like an infection), PRURITUS (itchy), VACCINATION SITE WARMTH (warm and hot to the touch), VACCINATION SITE MASS (bump/red bumpy circle), AXILLARY PAIN (it hurt all the way to the armpit/the whole shoulder and armpit area hurt quite significantly), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE ERYTHEMA (red patch/path started growing on vaccine site), LYMPH NODE PAIN (pain spread to the lymph nodes in my armpit), ARTHRALGIA (whole shoulder hurt quite significantly) and VACCINATION SITE PAIN (It was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was also taking birth control medications concomitantly. No treatment information was provided.
Myalgia, Arthralgia, Diarrhea, Fatigue, Chills Narrative: No further details given
16 yo accidentally given Moderna vaccine; A spontaneous report was received from a healthcare professional concerning a 16 year old who received Moderna's COVID-19 Vaccine (mRNA-1273) and a 16 year old was accidentally given the Moderna vaccine/product administered to patient of inappropriate age.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 29 Jan 2021, the physician called to report that a 16 year old patient was accidentally given the Moderna vaccine. The patient was "clinically fine". No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, 16 year old was accidentally given the Moderna vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273. There was no associated AEs with this case of inappropriate age at vaccine administration.
When administering the vaccines - she slumped back and her upper body started to shake for about 5 seconds. She did not respond for a few seconds and then was very slow to respond.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: Fj1685), on 08Jan2021 as dose 2, single (Lot number: EL0142) and on 08Sep2021 as dose 3 (booster), single (Lot number: Er8732) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "Gluten" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; VITAMIN D3; OMEPRAZOLE; LOSARTAN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN B12 [CYANOCOBALAMIN]; TERAZOSIN; ROSUVASTATIN. Past drug history included: Lactose, reaction(s): "Known allergies: lactose"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic.  In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.
For my second dose, after a couple of hours I started feeling "off". I was very sluggish and tired. My mind was foggy. I slept fairly well on Thursday evening. When I woke up on Friday morning, I had a pounding headache and my body ached. I was still sluggish and tired. Later that morning I also felt very nauseous. Pain relievers did not seem to help relieve any of my symptoms. I also had chills throughout the day. My arm and armpit hurt very bad throughout the day as well. Friday evening I did not sleep well. I was sweating and my body ached all over. Nothing seemed to provide relief. When I woke up on Saturday morning, I still had chills, body aches and a headache.  Pain relievers did seem to help. By about 2pm I started feeling better and like myself again.   Today is Monday and I do still have a sore arm and armpit. My armpit is swollen.
Back ache; Neck ache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269 and expiry date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2 (age at vaccination: 75-years-old), SINGLE for covid-19 immunisation. Medical history included spinal operation (back surgery) and nerve injury (nerve damage). The patient received dose 1 of BNT162B2 for covid-19 immunisation (Lot: EL1284) on 16JAN2021. The patient experienced back ache and neck ache on 10Feb2021. Therapeutic measures were taken as a result of back ache and neck ache (Treatment: Consumer stated. "I already take pain pills. From the back surgery that I had left some nerve damage. So I have been taking 'Norge' (further not clarified). I don't know I am way take Aspirin or anything. Right now I am taking Aleve along with it, 3 Aleve a day. The medication that I am taking prescribed my doctor too. First one is Xtampza 36mg twice a day. Other medication is OxyContin 20mg twice a day."). Outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Starting 4 days later, migraine to where I couldn't work, muscle and joint pain, body aches, fever, chills,