chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N) concerning a patient who in approximately February 2010, was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported, lot number 664653/1337Y). Concomitant medications not reported. Nurse reported the patient complained about severe arm pain. Patient said the arm pain lasted for two weeks. This may have been the patient's second vaccination with PNEUMOVAX 23. The nurse was concerned about the lot number and thought they may have received a "bad lot". The reporter did not specify if the patient sought medical attention. A lot check has been initiated. Follow up information has been received from the registered nurse regarding the 63 year old female patient who in approximately February 2010, was revaccinated with a second dose of PNEUMOVAX 23. At the time of the report, the patient had recovered. The registered nurse indicated that her office gives a lot of this vaccine and found it odd that there were three patients who had similar experiences in a short amount of time. The registered nurse contacted during telephone follow up could not supply the following information: date of birth, dates of vaccination and exact date of the event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of 3 reports from the same source. Additional information is not expected.
Pt's mother described an injection site reaction that was swollen and hard to the touch, as well as red and raised above the skin. Did not describe any other pain outside of regular arm soreness nor any itching. Diphenhydramine oral or topical was recommended by the pharmacist on duty whom she described the reaction to.
Swelling, inflammation, muscle pain in arm radiating to upper shoulder and chest (Rt side) beginning several hours post immunization, persisting for 4 days then resolving. Patient works for physicians and with infectious disease doctor. Determined as non infectious local reaction with observations and reevaluation if needed. Reaction resolved w/o sequelae.
Patient presented to facility with shortness of breath for past 11 days. Patient reported being COVID positive at previous facility, Urgent Care.
Body aches, repeated vomiting, extreme fatigue, weakness, pain/tenderness in arm and armpit area of right arm where shot was given.
uriticaria all over body, hands, palms, arms, torso, back, abdomen, itching, Small reddened diffuse bumps , mild R sided headache
Rash began 12 days after her shot. Mild rash from her shoulder to her elbow.  Slight itching.  No fever or aches.
Patient received the flu vaccine in her rt deltoid. Prior to administration, she was questioned about allergies or any previous reactions.  She had none. Shortly after she left the clinic, she returned complaining with sudden pain in her upper arm and was unable to open her car door.  On examination, her arm was swollen at the site of injection.  Again she was questioned about any allergies. She stated she had no discomfort with the injection but sudden pain when attempting to open her car door.  An ice pack was applied to the swollen area.  After a few minutes, the client stated her arm felt less painful. She was sent home with the ice pack and instructed to continue with ice for 24 hours and then heat if her arm was still swollen. She was also directed to consult her physician if her discomfort continued.
Fine rash on torso & limbs 37 weeks pregnant - referred pt to her doctor.
On Sun PM pt had joint pain in knees where hurt to walk. Also had throbbing ear pain and today (11/11) has a stiff neck and swollen glands. Saw a provider who ruled out meningitis. Pt reports no localized rxn or any previous problems with vaccines.
Covid-19 Vaccine was administered on 07/19/2021 at 1:45 PM after (15) minute observation patient c/o mild throat  discomfort.  Notified provider. Per provider observed patient for additional (15) minutes. Obtained vitals : (LA)130/80 mmhg Pulse: 62 Oxygen: 98% . Per provider okay to release patient home. Notified patient if symptoms worsen, please go to nearest emergency room and/or follow up with PCP. Patient verbalized understanding and agreed.
Chills, fever, nausea. Began in the evening and went away after about 24 hours
Pts. states she had a fever of 99.8, fatigue, localized redness at the injection site, and swelling of the left arm. Pt. states that all adverse effects resolved by the 30th of September 2020.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received BOOSTRIX (batch number J2NH5, expiry date 11th May 2018). On 1st May 2017, the patient received BOOSTRIX .5 ml. On 1st May 2017, immediately after receiving BOOSTRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unchanged. It was unknown if the reporter considered the injection site swelling to be related to BOOSTRIX. Additional details were provided as follows: The nurse stated that it had been 10 days post-vaccination and the swelling had not resolved.
product=COVID 19 Treatment; patient on paxlovid; product=COVID 19 Treatment; patient on paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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 "unknown" and all described as "product=COVID 19 Treatment; patient on paxlovid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe itching began in entire upper left arm. Redness subsided somewhat overnight, but left a large red patch on arm (midway between shoulder and elbow.)  No treatment so far.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On 27-APR-2015 and 16-JUN-2015, unspecified number of patients were vaccinated with an improperly stored doses of RECOMBIVAX HB and, oral, ROTATEQ lot # J005078 and expiration date 20-SEP-2015, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states her arm began getting sore the night of the vaccine and has continued to be sore still today. She has muscle weakness and pain in the right deltoid where the vaccine was administered. There is no sign of injury on her arm, the patient states the pain is in her muscle.
Myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia,  Raynaud's disease, swollen lymph nodes in neck and arm.  Continued treatment since 2009 from primary doctor, rheumatologist, and neurologist.
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of sore arm in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject was not using contraception and the method of conception was intrauterine insemination. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 4 November 2013 the subject received a dose of BOOSTRIX (intramuscular, unknown details) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age was calculated to be 30 weeks. The date of last menstrual period was reported as 9 April 2013. The estimated date of delivery was reported as 13 January 2014 per the subject. At the time of reporting, the pregnancy was ongoing. On 4 November 2013, within hours of vaccination with BOOSTRIX, the subject experienced sore arm (injection site). At the time of reporting the events were resolved. The subject reported that the event was related to the BOOSTRIX. 12 March 2014: No further information provided; patient lost to follow-up.
Local reddness, swelling, itching and pain at injection site and surrounding areas of arm. Stomach upset and diarrhea.
I did have COVID after my 2 vaccines- it was Aug of 2021; I did have COVID after my 2 vaccines- it was Aug of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 13:30 (Lot number: ER8727) at the age of 57 years as dose 2, single and administered in arm right, administration date 13Mar2021 14:30 (Lot number: EP7534) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer", start date: Jun2016 (unspecified if ongoing), notes: Removal of right kidney; "Gallbladder", start date: May2014 (unspecified if ongoing), notes: Removed; "Tonsils removed", start date: Jun1994 (unspecified if ongoing), notes: Removed; "Miscarriage" (unspecified if ongoing), notes: 4 Children, 2 miscarriage over 20years. Concomitant medication(s) included: LEXAPRO taken for anxiety (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Aug2021, outcome "unknown" and all described as "I did have COVID after my 2 vaccines- it was Aug of 2021". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) fine and normal, notes: Reg-Blood test when Getting check ups all fine and normal; sars-cov-2 test: (13Aug2021) positive, notes: After vaccine.  Follow-up attempts are completed. No further information is expected.
Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a nurse. This case involves an unknown age 45 months old patient who received 0.25mL FLUZONE QUADRIVALENT instead of the 0.5ml from the vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on 08-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine underdose (received 0.25 ml FLUZONE QUADRIVALENT instead of the 0.5 ml) It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Hospitialized HR 175/ beats / min.  Atrial fib,  now on O2.  third day from vac date, 10-13-2021, I experienced extreme body aches and  racing heart.  Went to Hospital..  Just starting care.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 11Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL oral, start date: 03Jan2022; EFFEXOR oral, start date: 01Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Adverse event experienced with a very strong metallic taste in his mouth a few hours after the first dose on 01Jun2022. All food consumed had a metallic taste. Patient took other medication in 2 weeks. Treatment using Paxlovid start date was 01Jun2022, lot number, FY9918, oral for treatment of COVID-19.He experienced significant muscle spasm in mid-lower, right-hand side of back while seated and drinking coffee about 24 hours after starting treatment. The painful muscle spasm was reported as continued in lower back at the time of reporting. He contacted doctor's office and was instructed to stop taking Paxlovid treatment. However, he had continued to take the medication. At the time of reporting, had completed doses for 01Jun2022 and 02Jun2022. Adverse events start date was 01Jun2022, start time: 03:00 PM, patient was not recovered without any treatment, and had no Known allergies. other medication in 2weeks product included Fiber supplement.
could not eat; not feeling well; Inflammation; sick; exposed to covid; could not move; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not move), PYREXIA (Fever), FEEDING DISORDER (could not eat), MALAISE (not feeling well) and INFLAMMATION (Inflammation) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028A21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    no known allergies.  Concurrent medical conditions included Asthma chronic (almost died from), Non-smoker and Abstains from alcohol.   In December 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced MOBILITY DECREASED (could not move) and PYREXIA (Fever). On an unknown date, the patient experienced FEEDING DISORDER (could not eat), MALAISE (not feeling well), INFLAMMATION (Inflammation), ILLNESS (sick) and EXPOSURE TO SARS-COV-2 (exposed to covid). In December 2021, MOBILITY DECREASED (could not move) and PYREXIA (Fever) had resolved. In January 2022, FEEDING DISORDER (could not eat) had resolved. At the time of the report, MALAISE (not feeling well), INFLAMMATION (Inflammation) and ILLNESS (sick) had resolved and EXPOSURE TO SARS-COV-2 (exposed to covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 102.7 102.7 F. On an unknown date, Blood test: Normal.         Concomitant product use was not provided by the reporter.  Action taken was dose increased wit respect to the event could not eat and unknown with respect to all the other events with respect to ADALIMUMAB (HUMIRA).  Treatment information was not provided.  The reporter's causality for the events of could not eat and patient had exposed to covid was not provided, not feeling well, inflammation, sick was no reasonable and fever was reasonable possibility with HUMIRA 40MG/0.4ML(ADALIMUMAB).  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-625949, MOD-2022-626070 (Patient Link).   Reporter did not allow further contact
Twelve hours after 1st dose , client developed a red rash with bumps on the back of her right knee itchy, hives. did not take anything.  The next morning it was gone.  Did not report until time for second dose 7 days later. Dose 2 withheld.
suspected cavitary lesion on lung; Chest pain while breathing; cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 11:30 (at the age of 27-years-old) (Batch/Lot Number: EWO167) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of BNT162B2 on 08Jun2021 (at the age of 27 years-old) for COVID-19 immunisation (Product=COVID 19, Brand= Pfizer, Lot number= EWO167, Lot unknown=False, Administration date=08Jun2021, Administration time=11:30 AM, Vaccine location=Left arm, Dose number=1). The patient's medical history and concomitant medications were not reported. On 04Jul2021 06:00, it was reported that the patient experienced Chest pain while breathing, cough, and shortness of breath. Did two separate rounds of antibiotics after doctors visit. No change in condition so the patient received chest X-ray, image showed a suspected cavitary lesion on lung. The patient underwent lab tests and procedures which included x-ray: a suspected cavitary lesion on lung on 04Jul2021.  Therapeutic measures were taken as a result of the events. The patient did not have COVID prior vaccination, and the patient was not covid tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Narrative:  Patient was vaccinated in timely manner in February and March. Despite being fully vaccinated, pt tested positive for COVID 9-10-21 and was hospitalized for hypoxia. Pt improved and was discharged
pt recv vax & devel mild varicella w/a few rashes;seen by MD;pt recovered;
She received the vaccine and got chills, freezing all the way through her.  She could not get warm, two blankets on her and a heated seat, and a microwave heating thing on her chest and stomach that lasted for about 45 minutes.  Later she started to get up and her legs would not work, they gave out.  She does use a walker and not able to walk.  She called 9-1-1 and they informed her that they felt that it was due to the vaccine, and helped her to get up and made sure she was able to use the walker, and informed her to have somebody check on her periodically to make sure that she was okay.  She did have soreness at the injection site, running a small fever, but  nothing that was too bad.
Red, round, red mark on arm, hot to the touch and hard. On day 3 started itching. 24 hours after injection chills, tired, fever, and achy.
JOINT PAIN.  Joint pain began in hands on Day 4 (Aug 12).  Pain spread to feet approximately one week later, and then quickly spread to other joints, including knees, hips, shoulders, elbows, and wrists.
pt recvd vax & exp arthus-like rxn ( erythema & tenderness, resembling a cellulitis), which extends from shoulder to elbow on the vaccinated arm w/in 24-48 hrs;
expired PROQUAD that was administered to a patient; 1 dose im; This spontaneous report was received from a physician concerning a 4-year-old patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were unknown.  On 31-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S005879, expiration date: 25-AUG-2020) intramuscularly for prophylaxis (expired vaccine used, incorrect route of product administration). The vaccine was noted to be expired after administration.
Difficulty breathing, consistently lightheaded, fogginess, inability to sleep and extreme difficulty waking in morning, severe shooting pain in right arm at sight of injection still months later, chest pain, eye pressure
Janssen 3/11/21. Pfizer 10/28/21. Positive on 6/12/22
1345 - Vaccine Given 1410 - Pt reported moderate-severe chest tightness that extended down bilateral sides. Lips and fingers were going numb and pt appeared pale. 02 via simple face mask at 5.5L started at this time. 1420 - symptoms "starting to get better" per patient but still reported tightness and that is was now moving slightly higher towards the throat. Ambulance called at this time. 1428 - Epi Pen given in left thigh 1430 - Patient reports feeling anxious and bilateral hands are beginning to contract with patient stating "I can't move my hands" Patient was taken to hospital via ambulance at this time 1430
THREE DEEP VEIN THROMBOSIS (DVT) LEFT LEG; BLOOD PRESSURE WENT UP; This spontaneous report received from a consumer via a company representative via a social media concerned a 92-year-old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had a blood clot in life. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after vaccination it was reported that the D-dimer level went up and later had three deep vein thrombosis (DVT) diagnosed in left leg. On an unspecified date, patient's blood pressure went up also.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the three deep vein thrombosis (DVT) left leg and blood pressure went up was not reported. This report was serious (Other Medically Important Condition). This case, from the Others is linked to 20211152736.; Sender's Comments: V0: 20211207894-COVID-19 VACCINE AD26.COV2.S-three deep vein thrombosis (DVT) left leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt vaccinated at 13:30, appeared to be without problem. Immediately after upon leaving the building, he became weak and dizzy. Complained of pain in limbs and nausea. Having difficulty ambulating.  BP: 120/74, Pulse: 80; RR: 24, 911 called.
Pt reports of "itching" to L lower back and bilateral ear "warmth" following J&J vaccine. RN noted 2 inch redness with blotchy hives to L lower back that pt had been scratching. Bilateral ears also red with warmth to touch. No other symptoms or complaints. Contact made with on call ER MD who gave verbal orders for Benadryl 50mg po in which pt tolerated very well. Within 10 mins of medication, pt reported "subsiding" of her reported symptoms and continued to remain free of any respiratory distress. At 30 minutes post medication, pt's itching with redness/blotchy hives to L lower back completely resolved.
Patient was given an expired dose of Pfizer vaccine. The vaccine had an expiration date of 8/2/22 and was administered on 8/4/22