chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with a Shingrix dose reconstituted with sterile water instead the ASO1B adjuvant; administered with a Shingrix dose reconstituted with sterile water instead the ASO1B adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and incorrect dose administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.  Additional details was reported as follows: The age at vaccination was not reported. The patient received shingrix reconstituted with sterile water instead of ASO1B adjuvant which led to wrong solution used in drug reconstitution and incorrect dose administered. The reporter consented to follow up. No other information was available.
Rash began and doctor said it was an immunization outbreak of Chicken Pox from the varicella vaccine.
No additional adverse effect reported; A patient was administered a dose of improperly stored ROTATEQ; third dose of ROTATEQ was on 29-JUN-2020; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding concurrent conditions, concomitant therapies, medical history and historical drugs was not provided.   On 27-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength, dose, lot # and expiration date were not provided); second dose was administered on 25-FEB-2020.  On 29-JUN-2020, patient was vaccinated withh a dose (third dose) of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S005875, expiration date 30-NOV-2020 for prophylaxis following temperature excursions.  Temperature excursion was reported as below 36°F (34.8°F) for 25 minutes and a previous excursion below 36°F (34.5°F) for 1 hour and 24 minutes.  The call was made due to a digital data logger. No adverse effects were reported.  This is one of several cases from the same reporter.
p/1st capsule devel fever on 10SEP til today of 101.5; no diarrhea; has felt malaise; no nausea; has sent culture but no result yet;
Covid arm pain redness at injection site rash swelling of upper arm   headache dizziness nausea weakness and fatigue
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4509360-00 (Agency).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. 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) all with onset 16Aug2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive, notes: On 16Aug2022, the patient experienced COVID-19. The action taken for adalimumab was unknown. Clinical course: Solicited report from a consumer of a 58 year old male with an event of non-serious covid-19 with Humira (adalimumab). There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The event abate after stopping drug was NA. Concomitant drugs not reported. Other relevant history was Not reported.  Causality for Humira (adalimumab): The reporter causality for the event(s) of covid-19 with humira(adalimumab) was no reasonable possibility. Causality: Covid-19 (covid-19). Action(s) taken with drug: unknown. Causality as per reporter (drug/vaccine): not related. Dechallenge: N/A Causality: Covid-19 (covid-19). Action(s) taken with drug: unknown. Causality as per reporter (drug/vaccine): possible. Dechallenge: N/A.  The reporter considered covid-19 related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and covid 19 cannot be ruled out.
received vaccine late afternoon on 12/29/2020, next day I awoke with a headache but started a CPAP machine same night so thought it was related to that. Started feeling fatigued and body aches all over; left work at 10:30 a.m. , went home and crawled into bed; kept fluids at my bedside, took 800mg ibuprofen every 8 hours for two days which helped almost 100%. Saturday 1/2/2021 my left arm began to itch, the area is red and is hot to the touch at this very moment.
69 patients had recieved expired vaccine / Dose administered after 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Reported that This lot was shipped on 12/6/2021 and the new expiration date should have been 1/5/2022 due to the refrigeration of the vaccine.  The error was caught on 1/11/2022 when a new shipment was received.
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.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 as dose 5 (booster), single (Lot number: FM0699) at the age of 85 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Only moderate hypertension" (unspecified if ongoing), notes: Only moderate hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Negative; (2022) Positive, notes: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: it was reported that case was non-serious. Patient was treated for COVID with anti-viral medication which started on 17Dec2022 to 22Dec2022. Other medication in 2 weeks was Lozartin. It was reported that rebound Covid. Test positive again one week after testing negative. No known allergies.
Breakthrough case admission after 3 vaccines Pfizer 10/15/21 lot# 301258A;  Pfizer 4/9/22 Lot# FK9895;  Pfizer 10/6/22 lot# GH9703
swelling/bumps that scattered around her injection site/lump that was there whole arm has spread down to my arm to my elbow and up to my shoulder and around the spreading back sides of my arm; swelling/bumps that scattered around her injection site/lump that was there whole arm has spread down to my arm to my elbow and up to my shoulder and around the spreading back sides of my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Oct2022, outcome "not recovered" and all described as "swelling/bumps that scattered around her injection site/lump that was there whole arm has spread down to my arm to my elbow and up to my shoulder and around the spreading back sides of my arm".  Additional information: COVID-19 Vaccine Bivalent was a Pfizer product. COVID-19 Vaccine Bivalent manufacturer was unspecified. NDC number/ UPC number of COVID-19 Vaccine Bivalent was unknown. Patient do not have the LOT. Expiry Date of COVID-19 Vaccine Bivalent was Unknown. Consumer (patient) called to find out if it is normal for a patient who received the Pfizer BionTech covid-19 Bivalent Booster Vaccine (Gray cap) 5 days ago to still experience swelling/bumps that scattered around her injection site. Patient stated that she received 4 doses of the Pfizer biontech covid-19 vaccine (2 shots for the monovalent primary series, 1 shot for monovalent booster dose and 1 shot for the bivalent booster). The last shot she received was last Sunday 23Oct2022 for the booster bivalent vaccine and stated that she still experienced swelling/bumps that scattered around her injection site. Caller specified that it extended to her elbow and shoulder as well as around her extremities. Caller also stated that she has autoimmune. Patient got a lump on her arm and that was not normal; has spread down to my arm to my elbow and up to my shoulder and around the spreading back sides of patient arm. patient just want to know is that normal for the lump to spread. It is been 5 days. Patient was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department. Product details (Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose at 5:30 ,  difficult breathing at 6:10 admin benadryl at 6:10 epi pen at 6:30
NO ADVERSE EVENT OCCURED, PATIENT IS NOT 18 YO UNTIL 7/19/2022. PATIENT RECEIVED 2 DOSES OF PFIZER, LAST DOSE 5/27/21.
Blurred vision. Unable to focus both eyes together, with or without prescription eyeglasses and/or contact lenses. Able to focus, see clearer with one eye closed at a time from both eyes.
Hurting her foot so bad; This is a spontaneous report from a contactable consumer or other non hcp reported. A 74-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Mar2021 (age at vaccination: 74 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received her 1st dose of the Pfizer Covid vaccine on 20Mar2021 and was scheduled for her 2nd dose on 14Apr2021 but she missed the 2nd dose due to her hurting her foot so bad. there was stated that patient couldn't walk or drive at that time. Agent relays she advised to contact the facility to reschedule. there was reported when patient got the 1st dose she couldn't tell she got it, she went home and her arm didn't get sore and she had no side effects, it went smooth. it was reported that patient weight was probably 170 and she is not sure, she lost some since she hurt her foot. It was stated patient had a problem sometimes breathing and she knew with her breathing problem that she didn't think she could take Covid 19 so she decided to take a chance on the shot. patient had been in contact with her drug store, they are usually really good and had an answer for everything, she asked the young lady to reschedule and was told to call a certain number and she gave it to her real fast and she didn't get it written down correctly. Stated she got on the computer to reschedule and it lets her put in everything but the date she took the 1st dose. The outcome of the event was reported as unknown.  Information about Lot/Batch number has been requested.
The patient complained of itching on day the vaccination, then applied sarna cream after scratching it. The patient complained of a black and bruise initially,  then the site progressed to redness. The patient went to the doctors office on 3/10/2021. The patient cefadroxil 500mg ( 1 capsule every 12 hours for 7 days).
exp body rash (large raised rash) from hip to knees, backs of arms & upper abd;2 days post vax treated @ local PMD w/DPH & pred;
Intense brain fog and dizziness caused by first vaccine. Worsened by second. Feeling of fullness in ears and occasional ear pain  along w tinnitus.
Redness, swelling, itchiness and soreness at injection site went away 5 days after vaccination, but then returned 7 days after vaccination and continued for 4 more days.
PATIENT EXPERIENCED SWELLING AT THE INJECTION SITE AND ARM PAIN SO THAT SHE COULD NOT LIFT HER ARM TO BRUSH HER TEETH STARTIN GON 11/11/2020. SHE TOOK TWO ADVIL AT NIGHT AND IN THE MORNING TO ALLEVIATE SYMPTOMS.
This spontaneous report as received from a medical assistant refers to a patient of unknown age, unknown gender. On 08-APR-2013 the patient was vaccinated subcutaneously with an expired dose of MMR II (lot # 670210/0447AA, expiry date 28-MAR-2013). It was unknown if this was the first or second dose of MMR II the patient had been administered. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Redness, swelling in injection site area (on left arm below injection site area) - warm to touch; pt not having any other symptoms-consulted MD (PCP)
A 66 year old subject had received 4 previous series of Tice BCG weekly bladder instillations, from approximately 03/1999 through 08/2001, with no problems reported.  Recently she began to receive a planned series of 6 weekly instillations of Tice BCG with interferon alfa-2b.  Following the first and second instillation (on 4 and 09/11/2002) she experienced a significant headache which lasted 2-3 days.  After the third and fourth instillation no headache was reported.  In addition to the headaches she experienced increased blood glucose levels after each BCG treatment.  The headaches were treated with tylenol which gave only partial relief.  The increased blood glucose levels were treated with additional insuline for 3 days after.
pt recvd vax; back & joint pain; as of 16nov93, joint discomfort cont w/ swelling; still has trouble walking; no fever or local rxn; sed rate elevated;
Client presented at the vaccination site on 03/20/22. RN interpreted for client?s mother. Client?s mother reported client received a first dose of Pfizer COVID vaccine on 02/27/22 (lot #: FL8095). Client?s mother reported within 24 hours of receiving the first dose of Pfizer COVID vaccine, client developed skin rash ?little bumps? warm to touch lasted for three days. Client?s mother reported she didn?t treat his skin rash with any medication or take him to follow-up with his PCP. Client?s mother reported client does not have any chronic illnesses, not taking any medications, and has no known allergy. Client?s mother is requesting for client?s second dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received second dose of Pfizer COVID vaccine, LOT#: FL8095 on 03/20/22 at 1534 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client?s mother on possible adverse reactions and when to seek EMS. Client?s mother verbalized understanding. Client left vaccination site with his mother at 1604 unassisted and with a steady gait.
Headache & NauseaVomiting Narrative: HA and nausea 5 hrs after 2nd shot adequately controlled withTylenol.
Pt woke up morning after rec'ing vaccine and along with expected side effects (fever, achy muscles), she also has a red raised rash on her face
nausea, dry heaves, headache, body aches treated with ibuprofen 200mg one time. Nausea and headache improved within 20-30 min. All symptoms resolved within 12 hours
Patient had stayed up from working MN's and went to doctor to receive final HPV vaccine. Had been feeling 'fine' --other than the normal post MN feeling. Had the injection administered about 12:30 pm--went home had something to eat, then went to bed. awoke about 5:00 pm this same day, with a headache, low grade fever, achiness, neck pain , and abdominal discomfort. temperature at @ 6 pm = 99.2 orally.pt took advil x 1. went to work at 9 pm this same day. started to feel much worse, increased fever, headache, and neck pain and 'feeling just run down all over'. patient could not work her mn shift, and was going to be escorted home. pt works in an Ed department and upon arrival of parents to pick her up, pt had an syncopal episode, pallor skin --almost white, with mild tremors. pt required stat ed care, which included a ct, lab, ivf (pt very dehydrated) required 3 liters of fluid, hr =tachy with low bp. spinal tap was done to r/o meningitis. pt 's lab revealed wbc with slight elevation. other labs wnl. temperature spiked to 102.5 rocephin iv given, and cultures drawn. pt started to feel better, after antipyretics , ivf's, and comfort/ sleep. discharged to home after 7 hours in the ed. pt remains with mild --cluster type headache controlled with pain medication. final dx= ? viral meningitis. 11/19/08-records received-final HPV4 vaccine received on-11/5/08-C/O headache, fever, neck pain, abdominal discomfort. General malaise and pale. Passed out.  Dehydration. Diagnosed with viral meningitis and discharged from ED. Continues to C/O mild headache and tiredness and slowly progressing. No C/O with 2 previous HPV4 vaccines.
heart fibrillations; heart fibrillations; A Spontaneous report was received from a Consumer, concerning a 65-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart fibrillations.    The patient's medical history was not provided. Concomitant medications included: warfarin sodium, benazepril and pantoprazole.  On 12-JAN-2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot number: 025L20A) at unknown site of administration and unknown route for prophylaxis of COVID-19 infection.  On 22-JAN-2021, the patient experienced heart fibrillation. On 23-JAN-2021, the patient had recovered from heart fibrillation.  On 8-FEB-2021, the patient again had experienced heart fibrillation and went to the emergency room (ER), the patient had recovered from heart fibrillation on the same day. The event of heart fibrillations was assessed as medically significant. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, heart fibrillation was considered as resolved.; Reporter's Comments: Very limited information regarding the events of cardiac fibrillation has been provided at this time. Further information has been requested.
Slight fever, pain at injection site. Left arm, red, warm, swollen at site of Pneumovax. Allergic reaction to Pneumovax v/s cellulitis. Benadryl 50mg ever 6 hrs prn. Keflex 500mg qid x 10 days.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-JUN-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 48 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient brought to the ED by EMS on 11/24 with increasing lethargy and fever. Two days prior (11/22) he tested positive for COVID-19. His facility was concerned his symptoms could indicate something critical so they called EMS. COVID PCR test done in the ED was also positive. Ultimately patient admitted 11/24/22 - 11/29/22 for COVID-19 infection with lethargy and poor p.o. intake.
Approximately 6 months after receiving the Pfizer Covid-19 Vaccine patient did come down with a positive case of Covid-19.  When this happened she experienced redness, swelling, and fever around her injection site in her left arm after all those months.
Information was received from an employee on behlf of her brother who reported an adverse event. A male experienced injection site redness, swelling, pain and hot to touch after immunization with BIOTHRAX. On 11Jun2013, the male received his sixth dose of BIOTHRAX by an unknown route in the right arm, lot FAV322A. On the same day he experienced redness, swelling, pain and hot to touch at the injection site. All symptoms resolved after 3 days. No medications or treatments were given for symptoms. BIOTHRAX immunizatoin history: Dose# 1 14Apr2007, FAV102 Dose #2: 05May2007, FAV102 Dose #3: 20May2007, FAV104 Dose #4: 12 Oct2010, FAV249 Dose #5: 01Dec2012, FAV309 Dose #6: 11Jun2013, FAV322A
Patient reported she developed hives a few days after receiving the flu shot. It started at her back as a big patch and spread throughout her body. It eventually spread from the back of the neck to her feet. The hives were worse at the sides and back.
Pt recvd DTP/HIB 30APR92 @ 2PM & 1AM 1MAY92 t104 R p/APAP given pt was taken to ER & t104.5 seen by MD CBC ordered & pt had elevated WBC; MD told mom was rxn to DTP;
I received the immun at around 11:00 am - by 12:00 I was feeling pain in my back, at 1:30 I started to get migraine, aura and tunnel vision, pain, for 12 hours. Last migraine at 15 years ago.
Given vaccines uneventfully, within 10-15 minutes became slightly listless and sleepy, started with projectile vomiting multiple times, clammy and pale, HR 120, temp decreased to 96.8, well perfused, no respiratory distress.  Patient continued to have vomiting and onset of diarrhea over next 2 hours and sent to ED where recovered without treatment.
Fever (100.8 F), chills, body aches, headache, patient feels rapid heart rate